FDA

Allergan caps a bad day with news the FDA has kicked back a supplemental application for cariprazine

Allergan $AGN is not having a good day today.

After posting some mixed, weak extended year-two data on its NASH drug, the company ended the day with a short note that the FDA had issued a refuse-to-file letter on its supplemental application for cariprazine as a new therapy for negative symptoms associated with schizophrenia.

David Nicholson, Allergan

The drug was already approved for schizophrenia and the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder. According to Allergan, the FDA told them that their application “was not sufficiently complete to permit a substantive review.”

RTFs have typically been rather rare, but the agency has handed out several this year, indicating their unhappiness with the way a drug application was filed.

An RTF means different things to different companies. Acorda just got hit, derailing a critical timeline for gaining a new drug approval. PTC was handed an RTF on Translarna, its failed Duchenne/cystic fibrosis drug, as a way the agency could try and slam the door on the application — though PTC has forced the issue and will now get a panel review next week. For Allergan, it could prove a temporary road block or a damning way to stop the drug in its tracks. Time will tell.

“We are disappointed with the FDA decision on our submission. We will request a meeting with FDA to discuss and determine our next steps. Vraylar is an important treatment option for patients suffering from bipolar I disorder and schizophrenia. We remain committed to our mental health program and to cariprazine and its potential as a treatment option for patients suffering from negative symptoms associated with schizophrenia,” said Allergan R&D chief David Nicholson.

 


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