- Biohaven Pharmaceutical will soon ask the Food and Drug Administration for approval of its second migraine drug after a large, late-stage study showed treatment eased pain and the most bothersome headache symptoms in significantly more trial participants than did placebo.
- The drug, called zavegepant, works similarly to Biohaven's approved migraine medicine Nurtec ODT, but is given intranasally via a spray rather than taken as a pill. Other medications for acute migraine treatment from Eli Lilly and AbbVie are also taken orally.
- Biohaven plans to file a new drug application for zavegepant with the FDA sometime in the first quarter of next year, the company said Monday. In a separate statement, Biohaven also announced that CEO Vlad Coric would become chairman of its board, while Matthew Buten, a former managing director at the venture firm Foresite Capital, would succeed James Engelhart as chief financial officer.
While a smaller biotech company, Biohaven has succeeded in a market led by large pharmaceutical firms like Lilly, AbbVie and, in the preventive treatment setting, Amgen, Teva and Lundbeck.
Biohaven's Nurtec ODT, which is approved as both an acute and preventive treatment, has exceeded expectations, quickly gaining market share and sales in the U.S. Its success has even drawn the attention of Pfizer, which last month paid $150 million in cash and invested $350 million in Biohaven stock to gain rights to sell Nurtec ODT outside the U.S.
That deal also included a similar ex-U.S. license to zavegepant, which now looks to be a smarter bet after the topline study success Biohaven reported Monday.
In the Phase 3 trial, which enrolled just over 1,400 people with a history of migraine, a single dose of zavegepant spray was tested against placebo as an acute treatment for a moderate or severe migraine attack. According to Biohaven, results showed zavegepant met both of the trial's main goals, outperforming placebo on both pain freedom and freedom from most bothersome symptoms at two hours.
Notably, the results appeared to show that zavegepant worked quickly, with a benefit over placebo as early as 15 minutes, and sustained pain relief through one to two days after.
Biohaven released only summary and limited information on side effects associated with zavegepant treatment, but said that the "majority" of adverse events were mild. A fifth of study participants given the drug experienced altered taste, compared to only 5% of those given placebo.
The company expects zavegepant, as an intranasal treatment, could be preferred by individuals seeking to avoid gastrointestinal side effects seen in small percentages of participants in clinical trials for Nurtect ODT, as well as Lilly and AbbVIe's oral migraine medicines.
Vamil Divan, an analyst at Mizuho Securities, wrote in a Dec. 6 note to clients that zavegepant "could be attractive to patients who suffer from significant nausea and vomiting when they get a migraine headache."
Full data from the trial will be presented at an upcoming medical meeting or published in a medical journal, Biohaven said.
Outside of migraine, however, Biohaven hasn't had as much luck in clinical development. Over the past two years, late-stage studies of experimental medicines for anxiety disorder, Alzheimer's and multiple system atrophy have failed, winnowing the company's pipeline.
Shares in Biohaven fell by 2.5% in early Monday morning trading.