Biohaven eyes mid-2021 for migraine prevention drug launch


Biohaven Pharmaceutical CEO Vlad Coric appeared on CNBC Wednesday to discuss the company’s efforts to market an oral solution designed to preempt migraine attacks.

After launching Nurtec ODT, an oral treatment for acute migraine attacks, earlier this year, the biotech firm now has its sights set on making that same therapy work to stop symptoms before they set in.

Biohaven took one step closer to making that a reality last month when the U.S. Food and Drug Administration accepted its application for review.

“I hope that in six months or so from now that we will be the first oral CGRP with the indication for the prevention of migraine,” he told Jim Cramer in a “Mad Money” interview. “Patients deserve to know that they can also prevent their next episode and not wait for that migraine to hit.”

When the protein CGRP, or calcitonin gene-related peptide, is released around the brain it produces pain associated with a migraine attack. Nurtec ODT was the first CGRP blocker in a tablet form to be approved by the FDA earlier this year.

Biohaven projects that the acute migraine treatment could be used as a prevention indicator in the middle of 2021. The FDA has given the company a second-quarter deadline, which is known as a PDUFA date, to review the drug application. PDUFA is an acronym for the Prescription Drug User Fee Act, which was passed in 1992 to fund the new drug approval process.

The FDA has previously approved multiple GGRP inhibitors for other drugmakers, though the medicines must be injected into the body.

“If we get approval in prevention, this will the first and only CGRP oral agent that would be indicated as dual-acting for acute and preventative therapy,” Coric said. “I hope one day in the near future patients … can take something to prevent their migraine with an oral medicine and not an injectable.”

Migraines, which can be debilitating headaches, is a poorly understood disease that often goes undiagnosed. About 39 million people suffered from the disease in 2019, according to the Migraine Research Foundation.

Coric said the company, which teamed up with celebrity Khloe Kardashian to help promote the tablet, is seeing “explosive growth” for Nurtec prescriptions since the launch. Biohaven has reported attaining more than 220,000 prescriptions since launching over six months ago.

Shares of Biohaven rose almost 2% on Wednesday, setting a record close of $98.24. The stock is up 80% year to date.

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