Biohaven drug could soon be approved to prevent migraines
Biohaven Pharmaceuticals is a step closer to being able to market its new migraine drug Nurtec as a preventative therapy.
The New Haven company announced Wednesday that the Food and Drug Administration has accepted its recently submitted supplemental New Drug Application (sNDA) for Nurtec ODT (orally disintegrating tablet).
The FDA approved the drug for acute migraine attacks in February.
While acute drugs aim to stop a migraine in progress, many chronic migraine sufferers are also prescribed preventative drugs to lessen the likelihood and frequency of the attacks.
The company cited clinical trial results showing patients who took 75 mg of Nurtec every other day experienced a statistically significant 4.3 day reduction from baseline in their monthly migraine days.
Biohaven said its goal is to offer patients the simplicity of managing their disease with one drug.
The FDA is reviewing the application and is expected to issue a decision during the second quarter of 2021.
Contact Natalie Missakian at news@newhavenbiz.com
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