Biohaven’s application rejected due to Apotex manufacturing issues

By Ben Hargreaves

- Last updated on GMT

Biohaven’s application rejected by FDA

Related tags Biohaven Apotex India Nurtec ALS

Biohaven’s sublingual Riluzole treatment for ALS receives a CRL from the US FDA due to the API being supplied by Apotex.

Biohaven Pharmaceutical released a statement​ on the complete response letter (CRL) it had received from the US Food and Drug Administration (FDA), which stated the only issue identified was that the active pharmaceutical ingredient (API) used was produced by Apotex Pharmachem.

The issue the FDA had with the application hinged on Apotex having provided the active pharmaceutical ingredient for a bioequivalent study in 2017, which had been manufactured between 2014 to 2016.

Apotex has experienced numerous manufacturing issues​ over the years, with Biohaven’s statement identifying that such issues had led to the withdrawal of 31 Apotex’s drug products​.

The company was applying for Nurtec (riluzole) to be approved as a sublingual treatment for amyotrophic lateral sclerosis (ALS). Currently, there are only oral tablet and oral suspension treatment options on the market.

According to Biohaven, the FDA had provided recommendations to Apotex as to how it could qualify previous API batches, which would have allowed for the approval of Biohaven’s product.

However, in a statement, Biohaven said, “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.”

From its side, Biohaven has supplied the FDA with additional information regarding the issue.

Robert Berman, Biohaven’s CMO, commented, “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."

After conducting the bioequivalence study with API provided by Apotex, Biohaven has subsequently moved onto using a different API supplier for commercial supply of the product.

Due to the delay of its application for Nurtec, Biohaven will divert funds away from the commercialization of Nurtec to other commercial areas of its business, the company stated.

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