Biohaven’s New Drug Application for Troriluzole Faces Regulatory Setback

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Biohaven, the clinical-stage biopharmaceutical company, has received news that the US regulators will not review its recently submitted new drug application for the treatment of patients with spinocerebellar ataxia (SCA) using troriluzole. The reason behind this decision is that the study’s primary endpoint was not met, and the regulators have deemed that a substantive review will not be permitted.

Share Prices Plummet Following Regulatory News

The announcement has had a significant impact on Biohaven’s share prices, which dropped over 30% during premarket trading on Thursday. This decline comes after an impressive performance earlier in the year, with the previous session ending at $23.80 per share – marking a gain of over 70% thus far.

Biohaven’s Commitment to Collaboration with the FDA

In response to the communication from the Food and Drug Administration (FDA), Biohaven has expressed its commitment to closely collaborating with the regulatory body. The company is determined to expedite the availability of troriluzole for individuals suffering from SCA3, especially since there are currently no approved therapies for this ultra-rare genetic disorder. To address the FDA’s concerns comprehensively, Biohaven intends to request a “type A” meeting within the next 30 days.

Disappointment over FDA’s Decision

The recent decision by the FDA not to review the submitted NDA has left many physicians, including Vlad Coric, deeply disappointed. As the chief executive and chairman, Coric expresses his frustration with the FDA’s failure to consider all available data regarding troriluzole’s disease-modifying effects on a genetic disorder that currently lacks approved treatments.

Troriluzole’s Safety Profile

Coric emphasizes that troriluzole’s active metabolite has a well-established safety profile and is highly tolerable. Due to its favorable risk-benefit profile, he believes that the FDA should have given it careful consideration for the disorder, considering its potential to make a significant impact.

Hope for Patients with SCA

The disorder in question is spinocerebellar ataxia (SCA), a debilitating and life-threatening condition. The company reports that approximately 200 patients have already undergone treatment with troriluzole for up to three years. Remarkably, these patients have shown stability in comparison to untreated individuals who have experienced significant disease progression during the same timeframe.

Understanding SCA

SCA is a group of dominantly inherited disorders that progressively affect the coordination of hands, arms, legs, balance, and speech. Patients face numerous challenges, including a decline in mobility that often leads to wheelchair dependence. Additionally, speech impairment hinders their ability to communicate effectively, while difficulty swallowing poses further obstacles. Sadly, SCA ultimately results in premature death.

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