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May 28, 2021

FDA: Biohaven’s migraine treatment can prevent headaches

PHOTO | Biohaven Pharmaceuticals has won FDA approval to market its new migraine pill Nurtec ODT to prevent headaches too.

Biohaven Pharmaceuticals on Thursday won FDA approval to market its new migraine pill Nurtec ODT as a preventative, giving the New Haven company the first drug on the market that can both prevent and treat the debilitating headaches, the company’s CEO said.

“We are the only company with one drug for acute and prevention. This has never happened before,” CEO Vlad Coric told New Haven Biz in an interview Friday morning. 

Biohaven launched the drug, its first commercial product, in March 2020 after the FDA approved it that year as an acute migraine treatment, meaning patients take it at the start of a headache to thwart an attack. 

The latest approval now allows people with “episodic” migraines, or fewer than 15 headaches a month, to take the drug up to 18 times a month. The drug has been shown to help prevent future migraine attacks in patients who take it every other day.

“It’s really streamlined and simple,” Coric said. “It’s one drug they can use acutely, and if they need to go to prevention they just take it a little more often.”

For those whose condition is not severe enough to warrant ongoing preventative treatment, the pill can still be taken temporarily to ward off attacks during migraine-triggering events, such as air travel, Coric said.

“You’d just take it every other day until you finish your vacation,” he said.  “Or, if you have an important life event coming up like a wedding, you may want to take your migraine pill ahead of time.”

Coric said the company will debut a series of new national television commercials over the weekend featuring Biohaven spokespeople Whoopi Goldberg, Khloe Kardashian and others to tout the new “prevent and treat” strategy.

The FDA based its Thursday decision on a Phase 3 study that showed Nurtec decreased monthly migraine days by 4.3 days a month after three months of treatment, outperforming a placebo. 

The drug is part of a newer class of migraine treatments known as CGRP (calcitonin gene related peptide) antagonists, which block a brain chemical that transmits pain. 

According to Coric, Nurtec is the only oral drug in that class to be approved for prevention, giving the company an advantage over Big Pharma competitors like Amgen, Eli Lilly and Teva Pharmaceuticals. 

Although those companies market injectable anti-CGRP drugs for migraine prevention, patients on those treatments must take a separate migraine drug to treat “breakthrough” attacks, he said. Meanwhile older migraine drugs like triptans can’t be used for prevention because they cause rebound headaches if taken too frequently. 

Coric said AbbVie, which makes Ubrelvy, the only other oral CGRP migraine drug approved by the FDA, is pursuing FDA approval for a separate preventative migraine pill, but that would still require patients to take a different treatment during attacks.

SVB Leerink analyst Marc Goodman predicted in a note Thursday that the FDA’s new approval would boost Nurtec ODT sales by $135 million, according to the trade publication FiercePharma. 

Contact Natalie Missakian at

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