FDA denial could delay launch of Minerva’s schizophrenia treatment roluperidone by at least two years: GlobalData

Following the news that the FDA denied approval for Minerva Neurosciences for its roluperidone for the treatment of negative symptoms in patients with schizophrenia; Christie Wong, Neurology Analyst at GlobalData, offers her view:

“The FDA has issued a Complete Response Letter (CRL) for Minerva Neurosciences’ roluperidone. It follows a refusal to file in October 2022 and two FDA Type C meetings in November 2020 and March 2022. To address the clinical deficiencies stated in the CRL, Minerva must provide additional safety and efficacy data for roluperidone including data to support concomitant antipsychotic usage. According to GlobalData’s Benchmark model, a Phase III clinical trial that investigates the safety and efficacy of a drug intervention for the treatment of schizophrenia has an expected trial duration of almost 23 months. This will delay the launch for at least two years, where the launch of other pipeline products is anticipated.

“Although the current schizophrenia treatment landscape includes many established atypical antipsychotic products that can help manage the positive symptoms of schizophrenia, patients still experience negative symptoms of the disorder, including avolition, social withdrawal, and flat emotional affect. Key opinion leaders (KOLs) previously interviewed by GlobalData agreed that the negative symptoms of schizophrenia have a major impact on the patient’s quality of life and that there is a need for novel treatment options to target the negative symptoms of schizophrenia.

“In addition to the regulatory snag, roluperidone will need to compete with Acadia Pharmaceuticals’ Nuplazid (pimavanserin tartrate), in Phase III development as an adjunctive therapy to atypical antipsychotics to target the negative symptoms of schizophrenia.

“However, should these products eventually receive regulatory approval, payers previously interviewed by GlobalData noted that products that target only the negative symptoms of schizophrenia may face restricted reimbursement in the US. While these products may improve the quality of life of patients by improving negative symptoms, they may not have a direct impact on cost offsets such as hospitalisations. As such, pricing and reimbursement may limit the potential of products that only target negative symptoms to gain market share.”