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ISSN (Print) 0012-6667 - ISSN (Online) 1179-1950
Published by Adis Homepage  [21 journals]
  • Vismodegib: A Review in Advanced Basal Cell Carcinoma
    • Abstract: Vismodegib (Erivedge®) is the first-in-class, oral small molecule inhibitor of the Hedgehog (Hh) pathway, abnormal activation of which is associated with basal cell carcinoma (BCC). In the USA, vismodegib is indicated for the treatment of adults with metastatic BCC (mBCC) or with locally-advanced BCC (LaBCC) that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. Similarly, in the EU, vismodegib is indicated for the treatment of adult patients with symptomatic mBCC, or with laBCC inappropriate for surgery or radiotherapy. The full European approval of vismodegib was based on the results of two phase II, open-label, noncomparative, international trials (ERIVANCE BCC and STEVIE), both of which showed high rates of tumour control in the indicated patient populations, including individuals with or without Gorlin syndrome. These studies also showed that vismodegib has an acceptable and manageable tolerability profile characterized by a number of class-related treatment-emergent adverse events, including muscle spasms, taste disturbances, alopecia, weight loss and asthenia (fatigue). Primary and secondary resistance to vismodegib has been documented, albeit at a low rate compared with some other targeted therapies. Vismodegib is therefore an effective and generally well tolerated systemic therapy for patients with mBCC and laBCC that can no longer be suitably controlled with surgery and/or radiotherapy. Historically, it is the first member of a class of drugs (Hh pathway inhibitors) that are now considered to be first-line treatment options for such individuals.
      PubDate: 2018-07-20
  • Alectinib: A Review in Advanced, ALK -Positive NSCLC
    • Abstract: Alectinib (Alecensa®) is a potent and highly selective anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor. Oral alectinib monotherapy is approved in the EU as first-line treatment for adults with advanced ALK-positive non-small cell lung cancer (NSCLC) and for the treatment of adults with advanced ALK-positive NSCLC previously treated with crizotinib. In the USA, alectinib is indicated for the treatment of adults with ALK-positive metastatic NSCLC. The recommended dosage for alectinib in the EU and USA is 600 mg twice daily. Well-designed phase III studies in patients with ALK-positive NSCLC showed that during up to ≈ 19 months’ follow-up, progression-free survival (PFS) was significantly improved with alectinib relative to crizotinib as first-line therapy (ALEX study), and relative to chemotherapy in patients previously treated with crizotinib and platinum-doublet chemotherapy (ALUR study). Central nervous system (CNS)-related outcomes were significantly improved with alectinib in both these settings. Two phase II registrational studies (NP28673 and NP28761) in patients previously treated with crizotinib also demonstrated the efficacy of alectinib, as assessed by objective response rates (ORRs), during up to 21 months’ follow-up. Overall, alectinib had a manageable tolerability profile in these settings, with most adverse events (AEs) of mild or moderate severity. Current evidence indicates that alectinib is an important treatment option for patients with advanced ALK-positive NSCLC who are previously untreated or those previously treated with crizotinib. Given its efficacy and tolerability, current guidelines include alectinib as a treatment option in these settings, with the NCCN guidelines recommending it as a preferred option for first-line therapy.
      PubDate: 2018-07-20
  • Targeting Gastrointestinal Transport Proteins to Control Hyperphosphatemia
           in Chronic Kidney Disease
    • Abstract: Management of hyperphosphatemia in patients with dialysis-dependent chronic kidney disease remains a major challenge, requiring a multifaceted approach that includes dietary phosphate restriction, dialysis, and phosphate binders. However, these treatments fail to meet serum phosphate targets in many patients, potentially further exacerbating the significant morbidity and mortality burden associated with the disease. Recent advances in our understanding of the mechanisms underlying phosphate homeostasis have shed new light on the issue and suggest that gastrointestinal transport proteins may be promising targets for new hyperphosphatemia treatments. Drugs that inhibit or downregulate these transport proteins, and thus reduce phosphate uptake from the gut, may overcome some of the limitations of existing phosphate-lowering strategies, such as interdialytic rises in serum phosphate levels, poor adherence to dietary and phosphate-binder regimens, and maladaptive responses that can increase gastrointestinal phosphate absorption. Here, we review the latest preclinical and clinical data for two candidates in this novel drug class: tenapanor, a small-molecule inhibitor of the sodium/hydrogen ion-exchanger isoform 3, and nicotinamide, an inhibitor of sodium–phosphate-2b cotransporters. We also discuss how potential synergies in their mechanisms of action suggest that coadministering phosphate binders with sodium–phosphate-2b cotransporter inhibitors may yield additive benefits over traditional phosphate-binder therapy.
      PubDate: 2018-07-18
  • Centrally Acting Agents for Obesity: Past, Present, and Future
    • Abstract: For many years, obesity was believed to be a condition of overeating that could be resolved through counseling and short-term drug treatment. Obesity was not recognized as a chronic disease until 1985 by the scientific community, and 2013 by the medical community. Pharmacotherapy for obesity has advanced remarkably since the first class of drugs, amphetamines, were approved for short-term use. Most amphetamines were removed from the obesity market due to adverse events and potential for addiction, and it became apparent that obesity pharmacotherapies were needed that could safely be administered over the long term. This review of central nervous system (CNS) acting anti-obesity drugs evaluates current therapies such as phentermine/topiramate, which act through multiple neurotransmitter pathways to reduce appetite. In the synergistic mechanism of bupropion/naltrexone, naltrexone blocks the feed-back inhibitory circuit of bupropion to give greater weight loss. Lorcaserin, a selective agonist of a serotonin receptor that regulates food intake, and the glucagon-like-peptide-1 (GLP-1) receptor agonist liraglutide are reviewed. Future drugs include tesofensine, a potent triple reuptake inhibitor in Phase III trials for obesity, and semaglutide, an oral GLP-1 analog approved for diabetes and currently in trials for obesity. Another potential new pharmacotherapy, setmelanotide, is a melanocortin-4 receptor agonist, which is still in an early stage of development. As our understanding of the communication between the CNS, gut, adipose tissue, and other organs evolves, it is anticipated that obesity drug development will move toward new centrally acting combinations and then to drugs acting on peripheral target tissues.
      PubDate: 2018-07-16
  • Correction to: Nonacog Beta Pegol: A Review in Haemophilia B
    • Abstract: The article Nonacog Beta Pegol: A Review in Haemophilia B, written by Yahiya Y. Syed, was originally published Online First without open access. After publication in volume 77, issue 18, pages 2003–2012 Novo Nordisk A/S requested that the article be Open Choice to make the article an open access publication. Post-publication open access was funded by Novo Nordisk A/S. The article is forthwith distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (, which permits any noncommercial use, duplication, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license and indicate if changes were made.
      PubDate: 2018-07-13
  • Assessment of the Risk of Rhabdomyolysis and Myopathy During Concomitant
           Treatment with Ticagrelor and Statins
    • Abstract: The introduction of ticagrelor, one of the first directly-acting oral antiplatelet drugs, provided new possibilities in the prevention of thrombotic events in patients with acute coronary syndromes (ACS). Current guidelines recommend ticagrelor in dual antiplatelet therapy with aspirin over clopidogrel for prevention of stent thrombosis in patients with ACS. Moreover, in the management of ACS, lipid-lowering treatment with high-intensity statin therapy is advised for secondary prevention of cardiovascular events over the long term. Despite the apparent advantages of combined antiplatelet and lipid-lowering treatments, a possible interaction between statins and ticagrelor may lead to myopathy and rhabdomyolysis. In this review, relevant information was gathered on the ticagrelor-statin interaction that might lead to this life-threatening condition. This review focuses on the most widely used statins—simvastatin, atorvastatin, and rosuvastatin. Possible mechanisms of this interaction are discussed, including CYP3A4 isoenzymes, organic anion transporter polypeptide (OATPs), P-glycoprotein and glucuronidation. PubMed database was searched for relevant case reports and all data gathered from the introduction of ticagrelor to March 2018 are presented and discussed. In summary, co-administration of statins and ticagrelor was found to be relatively safe in routinely prescribed doses. However, caution should be exercised, especially in elder populations.
      PubDate: 2018-07-12
  • Avatrombopag: First Global Approval
    • Abstract: Avatrombopag (Doptelet®) is an orally bioavailable, small molecule thrombopoietin receptor agonist that has been developed by Dova Pharmaceuticals for the treatment of thrombocytopenic disorders. In May 2018 avatrombopag received its first global approval, in the USA, for use in the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. A Marketing Authorization Application for use of avatrombopag in this indication was submitted to the EMA in April 2018. Clinical development of avatrombopag in the treatment of other thrombocytopenic disorders, including immune thrombocytopenic purpura and chemotherapy-induced thrombocytopenia, is ongoing. This article summarizes the milestones in the development of avatrombopag leading to this first approval for the treatment of thrombocytopenia in adult patients with CLD.
      PubDate: 2018-07-11
  • Erenumab: First Global Approval
    • Abstract: Amgen and Novartis are developing erenumab (AIMOVIG™, erenumab-aooe)—a fully human monoclonal antibody calcitonin gene-related peptide (CGRP) receptor antagonist—for the prevention of migraine. CGRP is a vasodilatory neuropeptide implicated in the pathophysiology of migraine and treatment with erenumab was associated with significant reductions in migraine frequency in phase II and III clinical trials. Based on these positive results erenumab was recently approved in the US for the preventive treatment of migraine in adults and has received a positive opinion in the EU for the prophylaxis of migraines in adults who have at least 4 migraine days per month. This article summarizes the milestones in the development of erenumab leading to this first approval.
      PubDate: 2018-07-02
  • The Future of IL-1 Targeting in Kidney Disease
    • Abstract: Interleukin (IL)-1α and IL-1β are proinflammatory cytokines that play a role in many diseases such as rheumatoid arthritis, juvenile rheumatoid arthritis, gout, and periodic inflammatory syndromes, including familial Mediterranean fever and Muckle-Wells syndrome. Drugs targeting IL-1 such as recombinant IL-1Ra (anakinra), neutralizing anti-IL-1β antibodies (canakinumab) and IL-1β traps (rilonacept) are in clinical use to treat these diseases. Additionally, experimental evidence suggests a role of IL-1 in kidney disease and hypertension and targeting IL-1 showed promising results in high cardiovascular risk patients, hemodialysis and renal transplantation patients. We now summarize knowledge on the potential role of IL-1 targeting in patients with kidney disease.
      PubDate: 2018-07-02
  • New Developments in the Management of Cytomegalovirus Infection After
    • Abstract: Cytomegalovirus (CMV) continues to be one of the most important pathogens that universally affect solid organ and allogeneic hematopoietic stem cell transplant recipients. Lack of effective CMV-specific immunity is the common factor that predisposes to the risk of CMV reactivation and clinical disease after transplantation. Antiviral drugs are the cornerstone for prevention and treatment of CMV infection and disease. Over the years, the CMV DNA polymerase inhibitor, ganciclovir (and valganciclovir), have served as the backbone for management, while foscarnet and cidofovir are reserved for the management of CMV infection that is refractory or resistant to ganciclovir treatment. In this review, we highlight the role of the newly approved drug, letermovir, a viral terminase inhibitor, for CMV prevention after allogeneic hematopoietic stem cell transplantation. Advances in immunologic monitoring may allow for an individualized approach to management of CMV after transplantation. Specifically, the potential role of CMV-specific T-cell measurements in guiding the need for the treatment of asymptomatic CMV infection and the duration of treatment of CMV disease is discussed. The role of adoptive immunotherapy, using ex vivo-generated CMV-specific T cells, is highlighted. This article provides a review of novel drugs, tests, and strategies in optimizing our current approaches to prevention and treatment of CMV in transplant recipients.
      PubDate: 2018-06-30
  • Empagliflozin: A Review in Type 2 Diabetes
    • Abstract: Empagliflozin (Jardiance®), a potent, highly selective, sodium glucose cotransporter-2 (SGLT2) inhibitor, is an effective and generally well tolerated antihyperglycaemic agent approved for the treatment of adults with type 2 diabetes (T2D) in the EU, USA and Japan, among other parts of the world. As with other members of its class, empagliflozin offers the convenience of once-daily oral administration and carries a low inherent risk of hypoglycaemia as a result of its insulin-independent mechanism of action, enabling it to be used as monotherapy and as a component of combination therapy with other antidiabetic agents with complementary modes of action to improve glycaemic control in patients with T2D. Beyond lowering glucose, empagliflozin exerts a favourable effect on a number of nonglycaemic outcomes, including modest reductions in bodyweight and blood pressure. As an adjunct to standard care, it demonstrated cardioprotective and renoprotective properties largely independent of glycaemic control in patients with T2D and established cardiovascular disease (CVD) in a mandated cardiovascular (CV) outcomes trial (EMPA-REG OUTCOME). Empagliflozin is generally well tolerated as monotherapy or as add-on therapy and, unlike canagliflozin (the only other SGLT2 inhibitor that has so far shown CV and renal benefits), it has not been associated with an increased risk of amputation or bone fractures. In conclusion, empagliflozin is a valuable treatment option for the management of T2D. Given its demonstrable cardioprotective benefits, the drug is worthy of preferential consideration in patients at high CV risk who require an (additional) antidiabetic medication in order to attain their glycaemic goal.
      PubDate: 2018-06-27
  • Anlotinib: First Global Approval
    • Abstract: Jiangsu Chia-Tai Tianqing Pharmaceutical and Advenchen Laboratories are co-developing anlotinib (Focus V®) for the treatment of advanced cancer. Anlotinib is an oral small molecule inhibitor of multiple receptor tyrosine kinases, with a broad spectrum of inhibitory effects on tumour angiogenesis and growth. Anlotinib is approved in China for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have undergone progression or recurrence after ≥ 2 lines of systemic chemotherapy. Anlotinib is also undergoing phase II and/or III clinical development for various sarcomas and carcinomas in China, USA and Italy. This article summarizes the milestones in the development of anlotinib leading to this first approval for NSCLC.
      PubDate: 2018-06-26
  • Regorafenib: A Review in Metastatic Colorectal Cancer
    • Abstract: Regorafenib (Stivarga®) is an oral small-molecule multiple kinase inhibitor. It is indicated worldwide for patients with metastatic colorectal cancer (mCRC). In the EU and USA it is indicated for patients with mCRC who have been previously treated with, or are not considered candidates for available therapies, including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and, if RAS wild-type, an anti-EGFR therapy. In Japan, it is indicated for the treatment of unresectable, advanced/recurrent CRC. The addition of regorafenib to best supportive care prolonged median overall survival (OS; by up to 2.5 months) and progression-free survival (PFS; by up to 1.5 months) relative to the addition of placebo in double-blind phase 3 studies (CORRECT and CONCUR) in patients with mCRC who had progressed after failure of standard therapy. Health-related quality of life was not adversely affected with regorafenib relative to placebo. A large open-label phase 3 study (CONSIGN) and several large real-world studies supported the efficacy of regorafenib in this setting. Regorafenib had a generally manageable tolerability profile, which was consistent with the profile of a typical small-molecule multiple kinase inhibitor. Treatment-related adverse events (AEs), mostly of mild or moderate severity, were reported in the majority of patients receiving regorafenib, with dermatological toxicities and liver enzyme elevations among the most common AEs. Although identification of biomarkers/parameters predicting efficacy outcomes with regorafenib will help to individualize therapy, current evidence indicates that regorafenib is a valuable treatment option for patients with refractory mCRC who have a very poor prognosis.
      PubDate: 2018-06-26
  • The Significance of the Intestinal Microbiome for Vaccinology: From
           Correlations to Therapeutic Applications
    • Abstract: Despite unprecedented advances in understanding the intestinal microbiome, its potential to improve fields such as vaccinology has yet to be realized. This review briefly outlines the immunologic potential of the intestinal microbiome for vaccinology and highlights areas where the microbiome holds specific promise in vaccinology. Oral rotavirus vaccine effectiveness in low-income countries is used as a case study to describe how the intestinal microbiome may be employed to improve a vaccine’s immunogenicity. A top-down, evidence-based approach is proposed to identify effective microbiota-based applications for vaccine improvement. Applying evidence from field studies in pertinent populations that correlate microbiome composition with vaccine effectiveness to appropriate experimental platforms will lead to the identification of safe, vaccine-supporting microbiota targets that are relevant to populations in need of improvement in vaccine-induced immunity.
      PubDate: 2018-06-26
  • Andexanet Alfa: First Global Approval
    • Abstract: Intravenous andexanet alfa [coagulation factor Xa (recombinant), inactivated-zhzo; Andexxa®] is a first-in-class recombinant modified factor Xa protein that has been developed by Portola Pharmaceuticals as a universal antidote to reverse anticoagulant effects of direct or indirect factor Xa inhibitors. In May 2018, andexanet alfa received its first global approval in the USA for use in patients treated with rivaroxaban and apixaban, when reversal of anticoagulant effects is required in life-threatening or uncontrolled bleeding. Intravenous andexanet alfa is under regulatory review in the EU and is undergoing clinical development in Japan. This article summarizes the milestones in the development of andexanet alfa leading to this first global approval for reversing anticoagulation of rivaroxaban and apixaban in adults.
      PubDate: 2018-06-20
  • Lisdexamfetamine Dimesylate: A Review in Paediatric ADHD
    • Abstract: Lisdexamfetamine dimesylate (lisdexamfetamine; Elvanse®; Tyvense®), an orally-active dexamfetamine prodrug, is indicated in the EU for the treatment of attention-deficit hyperactivity disorder (ADHD) in children aged ≥ 6 years (including adolescents) when the response to previous methylphenidate (MPH) treatment is clinically inadequate. The original approval of the drug was based on the results of phase III trials in children and adolescents with ADHD who had an inadequate response to previous pharmacotherapy (e.g. MPH) or were treatment naïve. In these studies, short-term treatment with flexibly-dosed lisdexamfetamine demonstrated greater efficacy than atomoxetine, based on a prospective comparison, and osmotic-release oral system (OROS)-MPH, based on a post hoc comparison. Improvements in ADHD symptoms were accompanied by improvements in health-related quality of life and functioning that were maintained as long as treatment with lisdexamfetamine was continued in a long-term extension of one of these trials. In subsequent phase IV head-to-head studies in adolescents with ADHD and an inadequate response to previous pharmacotherapy, lisdexamfetamine demonstrated greater efficacy than OROS-MPH when both medications were force-titrated, but not when they were flexibly-titrated. Lisdexamfetamine was generally well tolerated, with an adverse event profile (e.g. decreased appetite, headache, weight reduction, insomnia and irritability) typical of that reported for other stimulants. Thus, lisdexamfetamine provides an alternative option for the treatment of children and/or adolescents with ADHD who have not responded adequately to previous ADHD pharmacotherapies.
      PubDate: 2018-06-19
  • The Evolution of Lung Transplant Immunosuppression
    • Abstract: Advances in immunosuppression have been a key component to the ongoing success of lung transplantation. The demographics of patients receiving a lung transplant have evolved with older, more critically ill patients and those with previously contraindicated indications, now becoming recipients. Despite the lack of new classes of maintenance immunosuppression drugs becoming available, advances have been made in the prescribing of traditional immunosuppressive therapies. Developments in immunosuppressive regimens have seen changes in the route of administration, approaches to monitoring and combinations used. Long-term complications of immunosuppression, such as nephrotoxicity and malignancy can limit the success of lung transplantation, and strategies have evolved in recent years to minimise their long-term impact. Although survival outcomes have been steadily improving, chronic lung allograft dysfunction remains a barrier to long-term success. However, treatments for antibody-mediated rejection are emerging as a potential new therapeutic target to decrease the incidence of chronic lung allograft dysfunction. This article provides an update on the current status of immunosuppression after lung transplantation and reviews the evidence for immunosuppressive regimens and the implications for practice.
      PubDate: 2018-06-18
  • Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide: A Review in
           HIV-1 Infection
    • Abstract: Darunavir/cobicistat/emtricitabine/tenofovir AF (Symtuza®) is the first protease inhibitor (PI)-based single-tablet regimen (STR) available for the treatment of adults and adolescents (aged ≥ 12 years) with HIV-1 infection. It combines the PI darunavir (which has a high genetic barrier to resistance) with the pharmacokinetic booster cobicistat and the nucleos(t)ide reverse transcriptase inhibitors emtricitabine and tenofovir alafenamide (tenofovir AF), the latter being associated with less off-target tenofovir exposure than its predecessor tenofovir disoproxil fumarate (tenofovir DF). Over 48 weeks in phase 3 trials, darunavir/cobicistat/emtricitabine/tenofovir AF was noninferior to darunavir/cobicistat plus emtricitabine/tenofovir DF in establishing virological suppression in antiretroviral therapy (ART)-naïve adults and, likewise, was noninferior to an ongoing boosted PI, emtricitabine plus tenofovir DF regimen in preventing virological rebound in virologically-suppressed, ART-experienced adults. Resistance did not emerge to the STR components, with the exception being an emtricitabine resistance-associated mutation (RAM) [M184I/V] in one of seven recipients who experienced virological failure (although M184V was a minority variant at screening in this patient). Darunavir/cobicistat/emtricitabine/tenofovir AF was generally well tolerated, with renal and bone profile improvements but less favourable effects on some lipids versus tenofovir DF-based regimens. Thus, although longer-term and cost-effectiveness data would be beneficial, darunavir/cobicistat/emtricitabine/tenofovir AF is a welcome addition to the STRs available for the treatment of adults and adolescents with HIV-1 infection, being the first to combine the high genetic resistance barrier of darunavir with the renal/bone profile of tenofovir AF, thus expanding the patient population for whom an STR may be suitable.
      PubDate: 2018-06-18
  • Postural Orthostatic Tachycardia Syndrome: Prevalence, Pathophysiology,
           and Management
    • Abstract: Postural orthostatic tachycardia syndrome (POTS) is a debilitating disease that predominantly affects young women. It is a multifactorial disorder that is characterized by severe tachycardia and orthostatic intolerance. Patients with POTS experience a variety of cardiac, neurological, and immunological symptoms that significantly reduce quality of life. In this review, a comprehensive framework is provided to aid in helping identify and treat patients with POTS. Given its heterogenous nature, it is crucial to understand each component of POTS in relation to one another instead of distinct parts. The framework highlights the overlap among the five main subtypes of POTS based on its pathophysiology (neuropathic, hypovolemic, primary hyperadrenergic, joint-hypermobility-related, and immune-related). Emphasis is placed on incorporating a multidisciplinary approach when treating patients with POTS, especially with a new focus towards immunotherapy. Although research has advanced our knowledge of POTS, there is still a critically unmet need to further our understanding and provide patients with the relief they need.
      PubDate: 2018-06-15
  • Current and Emerging Therapeutics for the Management of Endometriosis
    • Abstract: Endometriosis is a chronic benign disease that affects women of reproductive age. Medical therapy is often the first line of management for women with endometriosis in order to ameliorate symptoms or to prevent post-surgical disease recurrence. Currently, there are several medical options for the management of patients with endometriosis. Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used in the treatment of chronic inflammatory conditions, being efficacious in relieving primary dysmenorrhea. Combined oral contraceptives (COCs) and progestins, available for multiple routes of administration, are effective first-line hormonal options. In fact, several randomized controlled trials (RCTs) demonstrated that they succeed in improving pain symptoms in the majority of patients, are well tolerated and not expensive. Second-line therapy is represented by gonadotropin-releasing hormone (GnRH) agonists. Even if these drugs are efficacious in treating women not responding to COCs or progestins, they are not orally available and have a less favorable tolerability profile (needing an appropriate add-back therapy). The use of danazol is limited by the large availability of other better-tolerated hormonal drugs. Because few data are available on long-term efficacy and safety of aromatase inhibitors they should be administered only in women with symptoms refractory to other conventional therapies in a clinical research setting. Promising preliminary data have emerged from multicenter Phase III trials on elagolix, a new oral GnRH antagonist but non-inferiority RCT data are required to compare elagolix with first-line therapies for endometriosis.
      PubDate: 2018-06-13
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