Biohaven receives CRL from FDA for application seeking NURTEC approval
Biohaven Pharmaceutical Holding Company announced that it has received a Complete Response Letter from the FDA for the 505b2 application seeking approval for NURTEC for ALS. The sole issue identified in the CRL relates to an FDA concern regarding the use of an active pharmaceutical ingredient 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. Of note, concerns with Apotex manufacturing recently led to the withdrawal of 31 Apotex drug products from the US market last 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 505b2 application for Nurtec. 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 is currently sourced from another supplier, with whom no CMC issues have been identified. Further, the FDA did not cite any other concerns in their CRL regarding Nurtec. Biohaven will be working with the FDA to develop a timely path forward. While timelines are developed to resolve this matter, Biohaven will re-deploy the associated funds for Nurtec commercialization to other commercial needs of the organization.