Allergan hit with FDA refusal to file letter
- Irish pharma Allergan on Friday received a refuse-to-file letter from the Food and Drug Administration for its already-approved drug Vraylar (cariprazine).
- Vraylar is on the market for the treatment of schizophrenia and the acute treatment of manic or mixed episodes in bipolar I disorder. The supplemental New Drug Application was aimed at adding an additional indication of the treatment of negative symptoms of schizophrenia.
- Allergan said it will seek clarification on next steps from the regulator, and is planning a meeting to respond to the issues raised.
During the first quarter of 2017, Allergan submitted an sNDA for Vraylar (cariprazine) for the maintenance of efficacy in adults with schizophrenia, which the FDA subsequently accepted in March. This was based on data from a Phase 3 study of Vraylar, which showed a significant delay in time to relapse compared with placebo.
"We are disappointed with the FDA decision on our submission," said David Nicholson, chief R&D officer at Allergan. "We will request a meeting with FDA to discuss and determine our next steps."
Vraylar's original FDA approval wasn't without its hitches.The drug was first rejected by the FDA in 2013, before being approved in September 2015 based on new Phase 3 data. It is also currently approved in Europe for schizophrenia.
Net revenues for the drug have grown in the two years since launch, reaching $66.3 million in the second quarter of 2017, compared with $11.1 million in the same quarter in 2016.
Development is also under way for other CNS disorders, although Allergan and partner Gedeon Richter, announced a year ago that Vraylar had not met the primary endpoint in a major depressive disorder trial.
Under the guidance of Commissioner Scott Gottlieb, the FDA has been issuing more refuse-to-file letters lately — potentially indicating that the agency is aiming to only review applications it believes are likely to get approved.
- Allergan Statement
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