Complete response letter given to ALS treatment for API concern

A Complete Response Letter (CRL) has been published by the US Food and Drug Administration (FDA) for the 505(b)2 application seeking approval for Nurtec™ (riluzole) for amyotrophic lateral sclerosis (ALS).

Biohaven Pharmaceutical Holding Company Ltd received the CRL regarding its drug. The issue identified relates to an FDA warning for the use of Apotex, an active pharmaceutical ingredient (API) manufactured by Apotex Pharmachem India Private Limited from 2014 to 2016. Concerns with manufacturing the API recently led to the withdrawal of 31 Apotex drug products from the US market.

The FDA provided recommendations to the API manufacturer regarding information that would be needed to qualify previous API batches manufactured during the time period. The manufacturer did not provide Biohaven with notice of the FDA communication, either during the course of its bioequivalence trial or during the submission of its 505(b)2 application for Nurtec (riluzole).

Biohaven has been subsequently informed by the manufacturer that it had an exemption from the FDA to supply riluzole to the US market. The pharmaceutical company has been in contact with the FDA and Apotex Pharmachem to resolve the matter.

The pharmaceutical company notes that the API for the commercial supply of Nurtec (riluzole) is currently sourced from another supplier, with whom no Chemistry Manufacturing and Controls (CMC) issues have been identified. 

“We are doing everything possible to work with the FDA and the API manufacturer to resolve this matter, which we believe to be more technical in nature,” said Robert Berman, Biohaven CMO and Nurtec (riluzole) Development Lead. “We believe that the quality issues surrounding the Apotex manufacturing facility do not affect the conclusions of our bioequivalence study but will work collaboratively with the FDA to resolve this matter as quickly as possible.”