Regulatory Setback For Minerva Neurosciences' Schizophrenia Treatment Candidate, FDA Asks For More Data
Regulatory Setback For Minerva Neurosciences' Schizophrenia Treatment Candidate, FDA Asks For More Data
Minerva Neurosciences Inc (NASDAQ:NERV) shares are trading lower after the FDA issued a Complete Response Letter (CRL) to the company's marketing application for roluperidone for the treatment of negative symptoms in patients with schizophrenia.
密涅瓦神经科学公司（纳斯达克股票代码：NERV）股价走低，此前美国食品药品管理局对该公司用于治疗精神分裂症患者阴性症状的罗卢潘立酮的上市申请发布了完整回复信（CRL）。
In the CRL, the FDA cited the following clinical deficiencies:
在CRL中，美国食品药品管理局列举了以下临床缺陷：
- Although one study (MIN-101C03) demonstrated statistical significance on the primary efficacy endpoint, it is insufficient on its own to establish substantial evidence of effectiveness.
- The application submission lacks data on concomitant antipsychotic administration.
- The NDA submission lacks the data needed to establish that the change in negative symptoms of schizophrenia with roluperidone treatment was clinically meaningful.
- The submitted safety database included an inadequate number of subjects exposed to roluperidone at the proposed dose (64 mg) for at least 12 months.
- To address these deficiencies, the FDA stated that Minerva must submit at least one additional positive, adequate, and well-controlled study to support the safety and effectiveness of roluperidone for treating negative symptoms.
- Minerva must also provide additional data to demonstrate the safety and efficacy of roluperidone co-administered with antipsychotic medications, to support that observed effect on negative symptoms with roluperidone treatment corresponds to a clinically meaningful change, and to demonstrate the long-term safety of the proposed dose.
- 尽管一项研究（MIN-101C03）显示了主要疗效终点的统计学意义，但其本身不足以确定大量的有效性证据。
- 提交的申请缺少有关同时使用抗精神病药物的数据。
- NDA提交的材料缺乏必要的数据，无法确定罗卢潘立酮治疗后精神分裂症阴性症状的改变具有临床意义。
- 提交的安全数据库包括在至少12个月内暴露于拟议剂量（64 mg）的罗卢潘立酮的受试者人数不足。
- 为了解决这些缺陷，美国食品药品管理局表示，密涅瓦必须至少再提交一项积极、充分且对照良好的研究，以支持罗卢潘立酮治疗阴性症状的安全性和有效性。
- Minerva还必须提供更多数据，以证明罗卢潘立酮与抗精神病药物联合使用的安全性和有效性，以支持观察到的罗卢潘立酮治疗对阴性症状的影响与具有临床意义的变化相对应，并证明拟议剂量的长期安全性。
"We believe that roluperidone is a safe and effective therapy for negative symptoms of schizophrenia, and we will review FDA's feedback and consider our potential paths forward, including continuing to work closely with the FDA and providing any additional information as needed," said Dr. Remy Luthringer, Executive Chairman and CEO of Minerva.
密涅瓦执行董事长兼首席执行官雷米·路斯林格博士说：“我们认为罗卢潘立酮是治疗精神分裂症阴性症状的安全有效疗法，我们将审查美国食品药品管理局的反馈并考虑我们潜在的前进方向，包括继续与美国食品药品管理局密切合作并根据需要提供任何其他信息。”
In addition to the clinical deficiencies, the FDA also provided comments on, among other items, clinical pharmacology, product quality, biopharmaceutics, and nonclinical issues.
除了临床缺陷外，美国食品药品管理局还就临床药理学、产品质量、生物制药和非临床问题等问题发表了评论。
Cash, cash equivalents, and restricted cash at December 31, 2023, were approximately $41.0 million.
截至2023年12月31日，现金、现金等价物和限制性现金约为4,100万美元。
Price Action: NERV shares are down 62.1% at $2.55 during the premarket session on the last check Tuesday.
价格走势：在周二最后一次盘前交易中，NERV股价下跌62.1％，至2.55美元。