After being denied FDA approval to treat amyotrophic lateral sclerosis (ALS), Biohaven’s Nurtec is now at risk of losing a critical share of the ALS market which is currently worth $239m and is set to grow to $1.2bn by 2027, according to GlobalData, a leading data and analytics company.
Nurtec, a revised version of riluzole, was at the pre-registration stage of development when the FDA denied its approval. Despite initially positive clinical trial results at Phase I which showed that the drug was safe and well tolerated in ALS patients, the FDA required more information about the active ingredient of the drug used in a study in 2017.
Magdalene Crabbe, Pharma Analyst at GlobalData commented: “This is an unfortunate setback for Biohaven and an obstacle that pharmaceutical companies must anticipate. With more than 56 drugs in clinical development for ALS in the seven major markets (7MM*), Nurtec is now at risk of losing a critical share, which would be a devastating blow to Biohaven in the neurology sector.”
Biohaven are now attempting to gather the required details from Apotex, a Canadian pharmaceutical company that violated the FDA’s good manufacturing practice (GMP) regulations.
Crabbe concludes: “In order to resolve the matter in a timely manner, Biohaven must prove that the results of the clinical trial are valid which is key to gaining approval.”
*7MM: US, France, Germany, Italy, Spain, UK and Japan