Biohaven earns preventative nod for migraine med Nurtec, snaring a much-needed leg up over AbbVie
Biohaven had a rough start to the year with failing data in Alzheimer’s that sent investor interest spinning out. But the drugmaker still had a lot of reason to believe in CGRP migraine med Nurtec despite a big challenge from AbbVie — and now that belief is continuing to pay off.
The FDA on Thursday approved Biohaven’s CGRP drug Nurtec ODT as a preventative treatment for migraine, making the drug the first and only option for both acute migraine care and prevention, the drugmaker said in a release.
With the approval in hand, Biohaven says its oral drug covers about 95% of available migraine patients, and it’s a needed boost, too: The CGRP market is growing fast and includes serious challengers like AbbVie’s Ubrelvy, which launched just a couple months before Nurtec’s curtain draw in early 2020.
The agency based its review on Phase III data showing Nurtec cut patients’ average migraine days by 4.3 per month compared with placebo and sliced the number of moderate-to-severe migraines per month by more than 50%.
Despite being the second-to-market oral CGRP and one of a group of drugs that have launched in the field on the whole in the last two years, Biohaven has differentiated Nurtec through its fast-acting formulation and durable efficacy over 48 hours, CEO Vlad Coric told Endpoints News in December.
“Timing in the market is very important, (but) a couple months is something you can handle if you have a better product,” Coric said at the time. “We have a best-in-class profile product.”
The prevention approval is just the first step in Biohaven’s plan for Nurtec, which will include a potential first-in-class nasal delivery approval, but also added indications outside of migraine where CGRP drugs have shown some early promise.
Another win for Nurtec is good news for Biohaven, which has seen at least one big setback in the rest of its pipeline. In January, the drugmaker rolled out data for its Phase II/III Alzheimer’s study for troriluzole, which flopped both co-primary endpoints as well as a key biomarker analysis.
The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB). The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.
That news sent shares plummeting, but $BHVN has since mostly recovered. Since a recent low of $66.05 earlier this month, the drugmaker’s shares opened at $84.73 on Friday.