Minerva again tangled in web of rejection after FDA nixes schizophrenia drug for 2nd time

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来源: FierceBiotech

To fix the many issues, the FDA is asking for at least one more positive, adequate and well-controlled study of roluperidone to support its use for the negative symptoms of schizophrenia.

Perhaps Minerva Neurosciences should have taken a page from the tale of Arachne: Never boast that you know better than the goddess of knowledge. Or in this case, the FDA.

The central nervous system-focused biotech’s schizophrenia drug has been roundly rejected by the agency, which said the studies submitted to support an approval did not establish evidence of effectiveness, lacked data and not enough patients were exposed to the proposed dose. The writing had been on the wall for years, and yet Minerva pushed on to have its application reviewed despite numerous warnings from the agency.

Minerva’s shares plunged by 58% as the markets opened Tuesday, falling to $2.72 compared to $6.80 at close Monday.

The company had been seeking an approval for roluperidone, also known as MIN-101, to treat the negative symptoms associated with schizophrenia. This is not the first time the FDA has said no. The agency issued a refusal to file letter for the application in October 2022, a rejection used when an application is not complete. The company appealed the refusal to file.

The FDA eventually agreed to take up review of the drug in May 2023 on appeal to consider the issues in the original refusal to file. The review was to be conducted on a standard timeline with a due date of February 26, bringing the story to today, when the application was officially rejected with a complete response letter.

“We are disappointed that the FDA has not approved roluperidone and will request a meeting to discuss the issues raised and attempt to address FDA’s feedback,” said Remy Luthringer, Ph.D., Minerva CEO.

The FDA flagged a number of clinical deficiencies in the application. While one study showed statistical significance on the primary endpoint, the agency said it was insufficient to establish substantial evidence of effectiveness. The submission did not have enough data to support concomitant antipsychotic administration, which is the use of two or more antipsychotic agents and is often standard treatment for patients with schizophrenia.

The submission also lacked data to establish that the changes in negative symptoms—social withdrawal, lack of interest, lack of motivation—were clinically meaningful. And finally, the FDA said the submission did not have adequate data from patients exposed to the proposed 64 mg dose for at least 12 months.

To fix these issues, the FDA is asking for at least one more positive, adequate and well-controlled study of roluperidone to support its use for the negative symptoms of schizophrenia. Minerva will also have to provide additional safety and efficacy data to support co-administration of the therapy with antipsychotic medicines, show a clinically meaningful observed effect on negative symptoms and to support long-term safety of the 64 mg dose.

The FDA also had notes on clinical pharmacology, product quality, biopharmaceutics and nonclinical issues.

“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, with the goal of bringing this much-needed therapy to patients and physicians,” Luthringer said.

In 2019, Minerva suffered a clinical failure of the major depressive disorder drug MIN-117. The only other therapy in the biotech's pipeline now besides roluperidone is MIN-301, which is in preclinical testing for Parkinson's disease.

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