The FDA’s decision sets back many years of effort by Minerva to secure approval of its drug for schizophrenia, called roluperidone and designed to treat so-called negative symptoms of the condition.
The company, which licensed rights to roluperidone from Mitsubishi Tanabe nearly two decades ago, advanced the drug into Phase 3 testing in late 2017 after promising mid-stage study results.
However, an initial phase of that study turned up negative data, prompting skepticism from FDA officials that Minerva had enough evidence to seek approval. The company pressed on, studying roluperidone in an open-label extension and submitting an application to the FDA in August 2022.
