Biohaven eyes mid-2021 for migraine prevention drug launch

Biohaven Pharmaceutical CEO Vlad Coric appeared on CNBC Wednesday to debate the corporate’s efforts to market an oral answer designed to preempt migraine assaults.

After launching Nurtec ODT, an oral therapy for acute migraine assaults, earlier this 12 months, the biotech agency now has its sights set on making that very same remedy work to cease signs earlier than they set in.

Biohaven took one step nearer to creating {that a} actuality final month when the U.S. Food and Drug Administration accepted its software for evaluation.

“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 advised 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 launched across the mind it produces ache related to a migraine assault. Nurtec ODT was the primary CGRP blocker in a pill kind to be authorized by the FDA earlier this 12 months.

Biohaven initiatives that the acute migraine therapy might be used as a prevention indicator in the course of 2021. The FDA has given the corporate a second-quarter deadline, which is named a PDUFA date, to evaluation the drug software. PDUFA is an acronym for the Prescription Drug User Fee Act, which was handed in 1992 to fund the brand new drug approval course of.

The FDA has beforehand authorized a number of GGRP inhibitors for different drugmakers, although the medicines have to be injected into the physique.

“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 mentioned. “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 might be debilitating complications, is a poorly understood illness that usually goes undiagnosed. About 39 million folks suffered from the illness in 2019, in line with the Migraine Research Foundation.

Coric mentioned the corporate, which teamed up with movie star Khloe Kardashian to assist promote the pill, is seeing “explosive growth” for Nurtec prescriptions because the launch. Biohaven has reported attaining greater than 220,000 prescriptions since launching over six months in the past.

Shares of Biohaven rose virtually 2% on Wednesday, setting a file shut of $98.24. The inventory is up 80% 12 months to this point.

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