US FDA accepts Teva-MedinCell’s new drug application for drug to treat schizophrenia


2021-09-01 23:30:34 PHARMACEUTICAL


Teva Pharmaceuticals and MedinCell’s new drug application for their drug, TV-46000/mdc-IRM to treat schizophrenia has been accepted by the US Food and Drug Administration . Intended for use as a subcutaneous injection, TV-46000 is an extended-release suspension of risperidone. This acceptance by regulatory agency is based on results from two Phase III clinical trials – RISE Study or and SHINE Study or TV46000-CNS-30078. RISE, or TV46000-CNS-30072, which is a multi-centre, double-blind, placebo-controlled study, analysed the efficacy of TV-46000 to treat schizophrenia in patients aged between 13 and 65 years. It saw enrolment of 544 subjects, who were randomised in a 1:1:1 ratio to get either a subcutaneous dose of TV-46000 once monthly (q1M) or once every two months (q2M) or a placebo. The study’s primary goal was the time to relapse. The SHINE Phase III trial evaluated the long-term safety, tolerability and efficacy of subcutaneous dose of TV-46000 given q1M or q2M for up to 56 weeks. It saw enrolment of 331 subjects, with the frequency of all adverse events (AEs), including that of serious AEs being the primary goal. This trial is currently underway and interim results were reported to be in line with data from the RISE Study. MedinCell CEO Christophe Douat said: “NDA file acceptance marks a major milestone for MedinCell, for our extended-release injectable technology, and for patients living with schizophrenia. “Through our strategic collaboration with Teva, we move one step closer towards helping patients and care-providers gain access to our extended-release subcutaneously injectable risperidone.” Teva will be responsible for the clinical development and regulatory activities and will oversee the marketing of the therapy candidate. MedinCell is eligible to get development and commercial milestone payments in the future besides royalty payments on net product sales.
Teva Pharmaceuticals和Medincell的新药TV-46000/MDC-IRM治疗精神分裂症的申请已被美国食品药品监督管理局接受。 用于皮下注射,TV-46000是利培酮缓释悬液。 监管机构的这一接受是基于两项III期临床试验的结果--RISE研究或和SHINE研究或TV46000-CNS-30078。 RISE或TV46000-CNS-30072是一项多中心、双盲、安慰剂对照研究,分析了TV-46000治疗13至65岁精神分裂症患者的疗效。 研究发现,544名受试者按1:1:1的比例随机接受皮下注射TV-46000,每月一次(q1M)或每两个月一次(q2M)或安慰剂。 这项研究的主要目标是复发的时间。 SHINE III期试验评估了给予q1M或q2M皮下剂量TV-46000长达56周的长期安全性、耐受性和有效性。 它观察了331名受试者,所有不良事件(AEs)的频率,包括严重AEs的频率是主要目标。 这项试验目前正在进行中,据报道中期结果与RISE研究的数据一致。 MedinCell首席执行官克里斯托弗·杜阿特(Christophe Douat)表示:“NDA文件的接受标志着MedinCell、我们的缓释注射技术以及精神分裂症患者的一个重要里程碑。 “通过与Teva的战略合作,我们向帮助患者和护理提供者获得我们的皮下注射利培酮缓释剂又迈进了一步。” Teva将负责临床开发和监管活动,并将监督候选疗法的营销。 MedinCell有资格在未来获得开发和商业里程碑付款,除了产品销售净额的版税付款。