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July 23, 2019 Bioscience Notebook

FDA shoots down Biohaven ALS drug over supplier concern

Photo | Contributed
By Natalie Missakian

Biohaven Pharmaceuticals’ recent momentum hit a speed bump last week when the FDA rejected its ALS drug, Nurtec, over concerns about the manufacturer of a key ingredient used in a 2017 clinical trial.

In a decision Biohaven made public late Friday, the U.S. Food & Drug Administration (FDA) took issue with the trial drug’s active ingredient, riluzole, which was manufactured in India by a Canadian generic drugmaker, Apotex.

Apotex has been in hot water with the FDA over manufacturing deficiencies at two India plants, leading to its decision to voluntarily pull 31 of its drug products from the U.S. market last year. The FDA formally withdrew its approval of those drugs on July 10.

Biohaven said it is now sourcing riluzole from a different supplier and was moving swiftly to address the FDA’s concerns, which its chief medical officer characterized as “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,” Chief Medical Officer Robert Berman, MD, said in a statement.

Nurtec is a new formulation of an older treatment for amyotrophic lateral sclerosis (ALS), a neurodegenerative condition also known as Lou Gehrig’s Disease. The disease causes progressive weakness and muscle atrophy. Biohaven’s version of the drug dissolves under the tongue, making it easier for ALS patients who suffer swallowing problems.

Although Biohaven’s flagship migraine drug rimegpant has received more of the spotlight, Nurtec was expected to be the first drug in the six-year-old company’s portfolio to win FDA approval. A decision on the migraine drug is also pending.

In its letter to Biohaven, the FDA said it gave Apotex recommendations about information it needed to qualify previous batches of riluzole manufactured between 2014 and 2016, according to the biotech. But Biohaven officials said Apotex never passed that information on to them.

Biohaven said it has since supplied additional information to federal regulators.

It was unclear Monday how long it could take to resolve the matter and what impact the setback might have on Biohaven’s timeline for bringing Nurtec to market if it’s ultimately approved.

“Biohaven will be working with the FDA to develop a timely path forward,” the company said in a statement. “While timelines are developed to resolve this matter, Biohaven will re-deploy the associated funds for Nurtec (riluzole) commercialization to other commercial needs of the organization.”

Spun out of Yale in 2013, Biohaven has 93 employees and operates out of 215 Church St. The company’s stock dipped slightly on the news but had recovered by Monday afternoon, closing at $45.25 a share. It was trading at $44.01 as of midday Tuesday.

Contact Natalie Missakian at news@newhavenbiz.com

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