• “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,” Biohaven Pharmaceutical CEO Vlad Coric told CNBC.
  • “Patients deserve to know that they can also prevent their next episode and not wait for that migraine to hit,” he said in a “Mad Money” interview.
  • “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,” he said, referring to the company’s Nurtec ODT that was released in early 2020.

 

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.

Read more here.

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