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.
密涅瓦神經科學公司（納斯達克股票代碼：NERV）股價走低，此前美國食品藥品管理局對該公司用於治療精神分裂症患者陰性症狀的羅盧潘立酮的上市申請發佈了完整回覆信（CRL）。
In the CRL, the FDA cited the following clinical deficiencies:
在CRL中，美國食品藥品管理局列舉了以下臨床缺陷：
- 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.
- 儘管一項研究（MIN-101C03）顯示了主要療效終點的統計學意義，但其本身不足以確定大量的有效性證據。
- 提交的申請缺少有關同時使用抗精神病藥物的數據。
- NDA提交的材料缺乏必要的數據，無法確定羅盧潘立酮治療後精神分裂症陰性症狀的改變具有臨床意義。
- 提交的安全數據庫包括在至少12個月內暴露於擬議劑量（64 mg）的羅盧潘立酮的受試者人數不足。
- 爲了解決這些缺陷，美國食品藥品管理局表示，密涅瓦必須至少再提交一項積極、充分且對照良好的研究，以支持羅盧潘立酮治療陰性症狀的安全性和有效性。
- Minerva還必須提供更多數據，以證明羅盧潘立酮與抗精神病藥物聯合使用的安全性和有效性，以支持觀察到的羅盧潘立酮治療對陰性症狀的影響與具有臨床意義的變化相對應，並證明擬議劑量的長期安全性。
"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.
密涅瓦執行董事長兼首席執行官雷米·路斯林格博士說：“我們認爲羅盧潘立酮是治療精神分裂症陰性症狀的安全有效療法，我們將審查美國食品藥品管理局的反饋並考慮我們潛在的前進方向，包括繼續與美國食品藥品管理局密切合作並根據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.
除了臨床缺陷外，美國食品藥品管理局還就臨床藥理學、產品質量、生物製藥和非臨床問題等問題發表了評論。
Cash, cash equivalents, and restricted cash at December 31, 2023, were approximately $41.0 million.
截至2023年12月31日，現金、現金等價物和限制性現金約爲4,100萬美元。
Price Action: NERV shares are down 62.1% at $2.55 during the premarket session on the last check Tuesday.
價格走勢：在週二最後一次盤前交易中，NERV股價下跌62.1％，至2.55美元。