Biohaven Pharmaceutical has failed to receive the US Food and Drug Administration (FDA) approval for Nurtec (riluzole).
Nurtec is a drug commonly used to treat amyotrophic lateral sclerosis (ALS) patients.
ALS is a neurodegenerative motor neuron disease that affects nerve cells in the brain and the spinal cord.
In its complete response letter, the regulator raised concerns about an active pharmaceutical ingredient (API) made by Apotex Pharmachem India between 2014 and 2016.
The API was also used in Biohaven’s 2017 bioequivalence study.
Recently, manufacturing concerns led to the withdrawal of 31 Apotex drug products from the US market.
According to the FDA, Apotex had been contacted for information regarding previous API batches manufactured at the company during 2014-16.
However, Biohaven noted that Apotex failed to notify them of any FDA communication during the course of bioequivalence trial or the regulatory submission for Nurtec.
Biohaven added that Apotex was subsequently informed about an FDA exemption to supply riluzole to the US market during that time period.
A statement from Biohaven read: “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.”
The company further said that the API is now being sourced from another supplier, who is claimed to have no chemistry, manufacturing and control issues.
Biohaven Pharmaceutical CMO and Nurtec development lead Robert Berman said: “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.”
“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.”
While the timelines are being worked out to resolve this matter, Biohaven plans to channelise the associated funds for Nurtec (riluzole) commercialisation to its other commercial needs.
Nurtec is being developed as a sublingual formulation to treat ALS.
The FDA previously approved oral tablet and oral suspension formulations of the drug for ALS.