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.
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 Allergen R&D chief David Nicholson.
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