FDA Still Has Concerns About Minerva NDA

Minerva Neurosciences says the minutes of its 3/2 Type C meeting with FDA on the development of roluperidone to treat negative symptoms of schizophrenia show the agency continues to have significant concerns about a proposed NDA while acknowledging an unmet need for negative symptom treatments and urging Minerva to continue its work. A company statement says FDA concerns included the applicability of the results of a Phase 2b study conducted in Europe to the U.S. population and the proposed use of post hoc analyses for the primary endpoint results of a Phase 3 study.

FDA also sought reassurance that Minerva could reliably identify patients who do not need antipsychotics and how to evaluate the stability of those patients, the company says.

Company officials say they are committed to continuing the dialog with FDA in anticipation of submitting an NDA this summer.