Minerva value plummets following FDA rejection of roluperidone


The stock market value of Minerva Biosciences has dropped nearly 60%, following the US Food and Drug administration (FDA) decision not to approve roluperidone for symptoms of schizophrenia.

The company received a ‘Complete Response Letter’ from the FDA highlighting the clinical deficiencies in its new drug application (NDA).

Although one study (MIN-101C03) demonstrated statistical significance on the primary efficacy endpoint, the FDA argued that it is insufficient on its own to establish substantial evidence of effectiveness.

The FDA also stated that the NDA lacked data on concomitant antipsychotic administration, as well as data needed to establish that the change in negative symptoms of schizophrenia with roluperidone treatment was clinically meaningful.

Dr Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva, commented: “There is a critical need for a treatment for the negative symptoms of schizophrenia. We believe that roluperidone is a safe and effective therapy for negative symptoms of schizophrenia and we will review the 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.”

New studies could delay roluperidone by two years

Minerva must now submit at least one additional positive, adequate, and well-controlled study to support the safety and effectiveness of roluperidone for the treatment of negative symptoms.

The company 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.

Christie Wong, Neurology Analyst at GlobalData, said: “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.

“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.”

Diana Spencer, Senior Digital Content Editor, DDW

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