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Susan J Keam
Vibegron is a selective beta 3 adrenergic receptor (β3 AR) agonist that is being developed in Japan jointly by Kyorin Pharmaceutical Co., Ltd and Kissei Pharmaceutical Co., Ltd and in other regions worldwide (except in several other Asian countries) by Urovant Sciences for the treatment of overactive bladder (OAB). Based on results from Japanese phase III trials, vibegron received approval in Japan in September 2018 for this indication. This article summarizes the milestones in the development of vibegron leading to this first global approval for the treatment of OAB...
November 8, 2018: Drugs
Hannah A Blair
Dolutegravir/rilpivirine (Juluca® ) is the first two-drug single-tablet regimen (STR) to be approved for the treatment of HIV-1 infection in adults. The fixed-dose STR combines the integrase strand transfer inhibitor dolutegravir with the non-nucleoside reverse transcriptase inhibitor rilpivirine. In two phase III non-inferiority trials (SWORD-1 and SWORD-2) in treatment-experienced patients already virologically suppressed on their current antiretroviral (ART) regimen, switching to once-daily dolutegravir plus rilpivirine maintained virological suppression over 48 weeks...
November 8, 2018: Drugs
Sheridan M Hoy
Fremanezumab-vfrm (hereafter referred to as fremanezumab) [AJOVY™] is a fully humanized monoclonal antibody (IgG2Δa) developed by Teva Pharmaceuticals to selectively target calcitonin gene-related peptide (a vasodilatory neuropeptide involved in the pathophysiology of migraine). Its use has been associated with significant reductions in migraine frequency, the requirement for acute headache medication use and headache-related disability compared with placebo in multinational, phase III studies, and in September 2018 fremanezumab was approved by the US FDA for the preventive treatment of migraine in adults...
November 8, 2018: Drugs
Mathew Suji Eapen, Philip M Hansbro, Anna-Karin Larsson-Callerfelt, Mohit K Jolly, Stephen Myers, Pawan Sharma, Bernadette Jones, Md Atiqur Rahman, James Markos, Collin Chia, Josie Larby, Greg Haug, Ashutosh Hardikar, Heinrich C Weber, George Mabeza, Vinicius Cavalheri, Yet H Khor, Christine F McDonald, Sukhwinder Singh Sohal
Chronic obstructive pulmonary disease (COPD) and lung cancer are major lung diseases affecting millions worldwide. Both diseases have links to cigarette smoking and exert a considerable societal burden. People suffering from COPD are at higher risk of developing lung cancer than those without, and are more susceptible to poor outcomes after diagnosis and treatment. Lung cancer and COPD are closely associated, possibly sharing common traits such as an underlying genetic predisposition, epithelial and endothelial cell plasticity, dysfunctional inflammatory mechanisms including the deposition of excessive extracellular matrix, angiogenesis, susceptibility to DNA damage and cellular mutagenesis...
November 3, 2018: Drugs
Simona Lattanzi, Francesco Brigo, Eugen Trinka, Gaetano Zaccara, Claudia Cagnetti, Cinzia Del Giovane, Mauro Silvestrini
BACKGROUND: Approximately one-third of patients with epilepsy presents seizures despite adequate treatment. Hence, there is the need to search for new therapeutic options. Cannabidiol (CBD) is a major chemical component of the resin of Cannabis sativa plant, most commonly known as marijuana. The anti-seizure properties of CBD do not relate to the direct action on cannabinoid receptors, but are mediated by a multitude of mechanisms that include the agonist and antagonist effects on ionic channels, neurotransmitter transporters, and multiple 7-transmembrane receptors...
November 3, 2018: Drugs
Caspar da Cunha-Bang, Carsten Utoft Niemann
Bruton's tyrosine kinase (BTK) is crucial in B-cell development and survival. The role of BTK as a downstream kinase in the B-cell receptor (BCR) signaling pathway is well described. As a key player in the pathogenesis of B-cell malignancies, targeting of dysregulated BCR signaling has been explored by development of inhibitors of downstream mediators. Discovery of the biological function of BTK and the development of covalent inhibitors for clinical use, ibrutinib as the lead agent and acalabrutinib as the second clinically approved BTK inhibitor, have revolutionized the treatment options for B-cell malignancies...
November 3, 2018: Drugs
Yvette N Lamb
Galcanezumab-gnlm (Emgality™; Eli Lilly and Company), hereafter galcanezumab, is a humanized monoclonal antibody against the calcitonin gene-related peptide (CGRP) ligand. A potent vasodilator, CGRP is implicated in nociceptive transmission and migraine pathogenesis. In September 2018, the US FDA approved galcanezumab as a once-monthly subcutaneous injection for the preventive treatment of migraine in adults. In the same month, the EMA issued a positive opinion for galcanezumab for the prophylaxis of migraine in adults who have at least 4 migraine days per month...
October 30, 2018: Drugs
Ana Isabel Fraguas-Sánchez, Ana Isabel Torres-Suárez
Cannabinoid receptors, endocannabinoids and the enzymes responsible for their biosynthesis and degradation constitute the endocannabinoid system. In recent decades, the endocannabinoid system has attracted considerable interest as a potential therapeutic target in numerous pathological conditions. Its involvement in several physiological processes is well known, such as in energy balance, appetite stimulation, blood pressure, pain modulation, embryogenesis, nausea and vomiting control, memory, learning and immune response, among others, as well as in pathological conditions where it exerts a protective role in the development of certain disorders...
October 29, 2018: Drugs
Matt Shirley
Fruquintinib (Elunate® ) is an orally available, potent and highly selective small molecule inhibitor of VEGFR-1, -2 and -3 that was discovered and developed by Hutchison MediPharma for the treatment of solid tumours. In September 2018, fruquintinib received its first global approval, in China, for use in the treatment of metastatic colorectal cancer (CRC) in patients who have failed at least two prior systemic anti-neoplastic therapies. Fruquintinib is in ongoing phase III clinical development for use in the treatment of advanced NSCLC and advanced gastric cancer...
October 24, 2018: Drugs
Sohita Dhillon
Moxetumomab pasudotox-tdfk (LUMOXITI™), an anti CD22 recombinant immunotoxin, has been developed by MedImmune and its parent company AstraZeneca for the treatment of hairy cell leukaemia. The product, discovered at the National Cancer Institute, is an optimised version of immunotoxin CAT-3888. Moxetumomab pasudotox is composed of the Fv fragment of an anti-CD22 monoclonal antibody fused to a 38 kDa fragment of Pseudomonas exotoxin A, PE38. The Fv portion of moxetumomab pasudotox binds to CD22, a cell surface receptor expressed on a variety of malignant B-cells, thereby delivering the toxin moiety PE38 directly to tumour cells...
October 24, 2018: Drugs
Weiyu Ye, Laura J Tucker, Laura C Coates
The introduction of biologic disease modifying anti-rheumatic drugs (bMDARDs) have revolutionised the treatment of psoriatic arthritis (PsA). This combined with a 'treat-to-target' approach, means that achieving remission is increasingly possible. In patients with well-controlled PsA, there is little consensus on whether bDMARDs should be continued, tapered or discontinued altogether. Tapering or discontinuation of bDMARDs could offer significant financial savings and minimise patient burden and unwanted drug-related side effects...
October 20, 2018: Drugs
Hannah A Blair
Pyrotinib is an irreversible dual pan-ErbB receptor tyrosine kinase inhibitor developed for the treatment of HER2-positive advanced solid tumours. Based on positive results in a phase II trial, the drug recently received conditional approval in China for use in combination with capecitabine for the treatment of HER2-positive, advanced or metastatic breast cancer in patients previously treated with anthracycline or taxane chemotherapy. This article summarizes the milestones in the development of pyrotinib leading to this first global approval for the treatment of HER2-positive advanced breast cancer...
October 19, 2018: Drugs
Sohita Dhillon
Ivosidenib (Tibsovo® ) is a small molecule, orally available inhibitor of mutated cytosolic isocitrate dehydrogenase 1 (IDH1) that is being developed by Agios Pharmaceuticals for the treatment of cancer in patients with IDH1 mutations. The mutated form of the IDH1 enzyme produces a metabolite, 2-hydroxyglutarate (2-HG), which is thought to play a role in the formation and progression of acute myeloid leukaemia (AML), gliomas and other cancers. Elevated 2-HG levels interfere with cellular metabolism and epigenetic regulation, thereby contributing to oncogenesis...
September 12, 2018: Drugs
Flaminia Coluzzi
Pain is one of the most common symptoms among patients with end-stage renal disease (ESRD), and is often under recognized and not adequately managed in hemodialysis (HD) patients. Barriers to adequate pain management include poor awareness of the problem, insufficient medical education, fears of possible drug-related side effects, and common misconceptions about the inevitability of pain in elderly and HD patients. Caregivers working in HD should be aware of the possible consequences of inadequate pain assessment and management...
September 11, 2018: Drugs
Emma D Deeks
Doravirine is a new non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Merck & Co for the treatment of HIV-1 infection. The drug is approved in the USA both as a single-agent tablet (Pifeltro™) and as a fixed-dose combination tablet with the nucleos(t)ide reverse transcriptase inhibitors lamivudine and tenofovir disoproxil fumarate (Delstrigo™). Each formulation is indicated in the USA for treating HIV-1 infection in adults with no prior antiretroviral treatment, has received a positive opinion in the EU for treating HIV-1 infection in adults without resistance to NNRTIs or (in the case of the fixed-dose combination tablet) lamivudine or tenofovir, and is also under regulatory review for the treatment of HIV-1 infection in Canada...
October 2018: Drugs
Matt Shirley
Dinoprostone vaginal insert (Cervidil® ; Propess® ), a retrievable vaginal pessary containing 10 mg of dinoprostone [prostaglandin E2 (PGE2 )] in a controlled-release drug delivery device, is approved in many countries worldwide for the initiation (or continuation) of cervical ripening in patients at term prior to labour induction. The device is designed to provide a constant and sustained release of dinoprostone to the cervix to promote the complex processes involved in cervical ripening. The vaginal insert is attached to a retrieval system that facilitates easy removal of the device at the onset of labour or in the event of complications...
October 2018: Drugs
Konstantinos Vazouras, Romain Basmaci, Julia Bielicki, Laura Folgori, Theoklis Zaoutis, Mike Sharland, Yingfen Hsia
PURPOSE: Urinary tract infections (UTIs) are common bacterial infections among children. OBJECTIVE: To systematically review the antimicrobials used for febrile UTIs in paediatric clinical trials and meta-analyse the observed cure rates and reasons for treatment failure. MATERIALS AND METHODS: We searched Medline, Embase and Cochrane central databases between January 1, 1990, and November 24, 2016, combining MeSH and free-text terms for: "urinary tract infections", AND "therapeutics", AND "clinical trials" in children (age range 0-18 years)...
October 2018: Drugs
Sheridan M Hoy
Sodium zirconium cyclosilicate (Lokelma™) [hereafter referred to as SZC] is a non-absorbed, non-polymer zirconium silicate compound that preferentially exchanges hydrogen and sodium for potassium and ammonium ions in the gastrointestinal tract (GIT), thereby increasing faecal potassium excretion and lowering serum potassium levels. It is available as a powder for oral suspension (in water) and is approved in the EU and the USA for the treatment of hyperkalaemia in adults. In two multinational, phase III studies in adults with hyperkalaemia, SZC 10 g three times daily lowered serum potassium levels to within the normal range (3...
October 2018: Drugs
Sean Duggan
Ablynx, a Sanofi Company, has developed the anti-von Willebrand factor Nanobody® caplacizumab (Cablivi™) for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP). Based on positive results in phase II and III trials in patients with aTTP, caplacizumab was recently approved in the EU for the treatment of adults experiencing an episode of aTTP, in conjunction with plasma exchange and immunosuppression. This article summarizes the milestones in the development of caplacizumab leading to this first approval...
October 2018: Drugs
Anthony Markham
The article Delafloxacin: First Global Approval, written by Anthony Markham, was originally published Online First without open access.
October 2018: Drugs
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