Complete Response for Nurtec to treat Amyotrophic Lateral Sclerosis

Biohaven Pharmaceutical Holding Company Ltd. announced that it has received a Complete Response Letter (CRL) from the FDA for the 505(b)2 application seeking approval for Nurtec (riluzole) for Amyotrophic Lateral Sclerosis (ALS).

The sole issue identified in the CRL relates to an FDA concern regarding the use of an active pharmaceutical ingredient (API) that was manufactured by Apotex Pharmachem India Private Limited between 2014 to 2016 and used in the drug product supplies for the bioequivalence study in 2017. Concerns with Apotex manufacturing recently led to the withdrawal of 31 Apotex drug products from the US market on Wednesday, July 10th 2019.

In the CRL, the FDA stated that it provided recommendations to Apotex regarding the information that would be needed to qualify previous API batches manufactured at Apotex during the time period in question. Apotex 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 they had an exemption from the FDA to supply riluzole to the U.S. market during that time period. Today, Biohaven has been in contact with the FDA's CMC group and Apotex to resolve the matter and Biohaven has already submitted additional information to the FDA regarding this issue. Biohaven notes that the API for commercial supply of Nurtec (riluzole) is currently sourced from another supplier, with whom no CMC issues have been identified.