Minerva's roluperidone faces many hurdles before FDA approval, says analyst

US clinical-stage biotech Minerva Neurosciences (Nasdaq: NERV) has recently received a refusal to file letter from the Food and Drug Administration (FDA) regarding its new drug application (NDA) for roluperidone, which was filed in August, for the treatment of negative symptoms in patients with schizophrenia, is yet another obstacle to the drug’s development.

According to data and analytics company GlobalData’s report, ‘ Schizophrenia Market Size and Trend Report including Epidemiology and Pipeline Analysis, Competitor Assessment, Unmet Needs, Clinical Trial Strategies and Forecast, 2021-2031’, prior to this news, it was assumed that roluperidone would launch in third-quarter 2023 in the USA and generate $70.3 million in sales by 2031. GlobalData forecasts that Nuplazid will generate $216.8 million in sales in the USA by 2031.

Commenting on the development GlobalData’s pharm analyst Christie Wong said: “The refusal to file letter follows two FDA Type C meetings in November 2020 and March 2022. In the most recent Type C meeting, the FDA voiced concerns regarding roluperidone’s failure to meet the primary efficacy endpoint in one of its two pivotal trials, specifically the one conducted in the US. Although the reasoning behind the FDA’s refusal to file letter has not been disclosed, it’s possible the agency still has some unaddressed concerns.”