FDA knocks back Biohaven’s ALS drug over manufacturing concerns

pharmafile | July 22, 2019 | News story | Sales and Marketing Biohaven, FDA, Nurtec, amyotrophic lateral sclerosis, pharma 

Biohaven Pharmaceutical has seen its new therapy formulation for the treatment of amyotrophic lateral sclerosis (ALS) rejected by the FDA, it has emerged.

The company revealed that the application for Nurtec, a sublingual form of riluzole – which is itself already the only FDA-approved therapy to extend tracheostomy-free survival of ALS patients, but in oral tablet form – had been met with a complete response letter from the US regulator. Biohaven’s shares dropped by around 6% as a result of the news.  

The letter highlighted concerns over the use of an active pharmaceutical ingredient (API) used by Biohaven in a 2017 bioequivalence study. The API was manufactured by India’s Apotex Pharmachem between 2014 and 2016, which recently saw 31 of its generic drug approvals withdrawn over issues at the company’s manufacturing facilities following three warning letters from the FDA in four years.

While the FDA made recommendations to Apotex on the steps needed to qualify any API batches manufactured between 2014 and 2016 for commercialisation, Biohaven said it was not made aware of this correspondence. The company said it had later been informed by Apotex that the manufacturer had received an “exemption” to supply these aforementioned batches to the US market.

Robert Berman, Biohaven’s Chief Medical Officer and Development Head for Nurtec, commented: “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.”

Biohaven confirmed that it has begun work with the FDA to resolve this issue, including the submission of additional information, as well as the fact that it has sourced the API in question from a different supplier “with whom there are no issues”.

Matt Fellows

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