England's NICE backs Pfizer's Vydura as treatment for acute migraines

Less than four months after recommending Pfizer’s Vydura (rimegepant) to prevent migraine headaches, England’s National Institute of Care and Health Excellence (NICE) has given it a thumbs up to treat them.

Vydura is expected to become the first medicine approved in the U.K. for episodic (acute) migraine attacks. The drug—known commercially in the United States as Nurtec—was approved by the FDA for acute attacks in February of 2020 and then 15 months later as a preventative therapy. In 2022, the European Union signed off on both uses of rimegepant.

In May, when NICE signed off on the use of Vydura to prevent migraines, it also recommended its approval to treat acute attacks, but only for fourth-line use and with other restrictions. The new endorsement would provide approximately 13,000 patients with access to the drug, NICE said.

This time, NICE still stopped short of recommending Vydura for primary use. According to the draft guidance, rimegepant is endorsed for adults who have had unsuccessful results with at least two triptan medicines. Vydura also is suggested for use by those who can't take triptans and had unsuccessful results with nonsteroidal anti-inflammatory drugs (NSAIDs) or the beta blocker paracetamol.

“NICE understands that rimegepant could eventually be used in primary care but should initially be started in secondary care,” the regulator said in its release. “This approach means there is flexibility in how this could be implemented at a local or regional level in the future.”

Rimegepant is a wafer that dissolves under the tongue and has been shown to reduce pain within two hours of ingestion. It halts the release of a protein called calcitonin gene-related peptide (CGRP) that is believed to cause the pain associated with migraine attacks. The cost of a 75 mg tablet in the UK is £12.90 ($16.12), NICE said.

Rimegepant was developed by Biohaven and acquired by Pfizer in its $11.6 billion buyout of the company. Pfizer reported (PDF) in July that Nurtec generated $247 million in sales in the second quarter of this year.

Also up for a NICE decision this year is another CPRG antagonist migraine treatment, AbbVie’s Qulipta, which the FDA blessed in 2021 as a preventative and in April of this year as a remedy for chronic migraines, which are more debilitating and occur more often—at least 15 times per month—than episodic attacks. Qulipta sales reached $96 million in the second quarter of this year.

Migraines are two to three times more common in women and often begin between the ages of 35 and 45, with hormonal changes often the trigger. Up to 43 million workdays are lost each year in the UK to migraine-related absenteeism, Pfizer said. In addition, it is estimated that migraine may cost the UK economy between £6 billion ($7.5 billion) and £10 billion ($12.5 billion) per year in total healthcare and productivity costs.