Biohaven had little trouble gaining approval in the U.S. and the EU for its migraine medicine Nurtec (rimegepant), as regulators have signed off on the medicine to both treat and prevent attacks.
Convincing experts of its value and safety in the British Isles hasn’t been as easy. Tuesday, the National Institute for Health and Care Excellence (NICE) recommended approval of the oral CGRP antagonist but with lots of restrictions.
NICE endorsed Vydura—the med's commercial name in Europe—only as a fourth-line option for those who have between four and 15 migraine attacks per month. Users must have already tried three other oral preventive treatments—tricyclic antidepressant amitriptyline, beta blocker propranolol and epilepsy drug topiramate.
Additionally, if Vydura doesn’t reduce attacks by half within 12 weeks, it should be discontinued, NICE says.
The ruling comes three months after NICE recommended against Vydura’s use to combat attacks as they occur.
Meanwhile, in Scotland, regulators have signed off on Vydura to treat acute migraines but have rejected it as a preventive option.
It will be interesting to see whether there is similar hesitance in the U.K. to give a thumbs up to another CGRP drug, AbbVie’s Qulipta, which is up for a NICE decision later this year. The FDA blessed Qulipta as a preventive in 2021 and for chronic migraines last month.
Since Pfizer completed its acquisition of Biohaven for $11.6 billion last year, it has not been smooth sailing for Nurtec. In March, the company recalled 4.2 million units because of a failure to comply with childproof packaging requirements, which created a potential risk of poisoning kids.
The FDA signed off on Nurtec for treatment of acute migraines in February of 2020. Fifteen months later, the U.S. regulator approved its use as a preventive option. Last year, the European Medicines Agency signed off on the CGRP antagonist for both uses.
Pfizer reported sales of $167 million for Nurtec/Vydura in the first quarter of this year.