Biohaven Pharmaceutical Holding Co. has reported that its new treatment for armyotrophic lateral sclerosis, or Lou Gehrig’s disease, has failed to win FDA approval.
The company announced Friday that the FDA said in a complete response letter that it is concerned about an API that was used in a 2017 study of the drug, Nurtec, that was produced by Apotex Pharmachem India, who had been in communication with the FDA about qualifying certain batches.
The company said it is now sourcing the API from another supplier and that it is working with the agency to resolve the matter.
Biohaven’s Nurtec is a generic sublingual form of riluzole, which is used to treat ALS. But because many ALS patients have trouble swallowing, Biohaven believes the sublingual delivery will give it an edge in the market.
Read the Reuters report.
