After receiving approval from the US in 2020 and the European Union in 2022, the new migraine treatment is now available to thousands of people in England and Wales.
Britain’s National Institute for Health and Care Excellence (Nice), the medicines regulator, has recommended eptinzumab to prevent migraines in around 164,000 adults where at least three previous preventive treatments have failed. The drug, also called Vyepti, is taken in hospital every 12 weeks as an intravenous infusion. The drug was found to be as effective as three other drugs already approved for home injection – erenumab, fremanezumab and galcanezumab.
All four drugs are calcitonin gene-related peptide (CGRP) inhibitors, which work by targeting how proteins cause blood vessels in the brain to swell.
The US Food and Drug Administration (FDA) approved eptinzumab based on evidence from two clinical trials (Trial 1/ NCT02559895 and Trial 2/ NCT02974153) of 1741 subjects with chronic or episodic migraine headaches conducted at 212 sites in the US, Georgia. Russia, Ukraine and the European Union.
In November 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the marketing authorization of the drug Vyepti, intended for migraine prophylaxis. The applicant for this medicinal product is H. Lundbeck A/S. Eptinezumab was approved for medical use in the European Union in January 2022.
Migraines are common, affecting about one in five women and about one in 15 men. They usually start in early adulthood. In addition to the throbbing pain in the head, many people suffer from other symptoms such as nausea, vomiting, and increased sensitivity to light or sound. Eptinezumab costs around £5,870 for a year’s treatment, although pharmaceutical company Lundbeck has agreed to provide it to the NHS at a confidential discounted price, Nees said.