The National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending the use of AbbVie’s migraine drug Aquipta (atogepant), for NHS use in adults in England.

Aquipta is an oral calcitonin gene-related peptide receptor antagonist that is used for the prevention of both chronic and episodic migraines. In the final draft guidance that was released on 11 April, the drug is recommended as an option for the prevention of migraines in adults who have at least four migraine days per month, only if at least three preventive medicines have failed.

The drug received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in September 2023 following positive data from two Phase III clinical trials, ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which assessed a 60mg once-a-day dose of Aquipta in adults with episodic and chronic migraine, respectively.

Data from both trialsshowed that Aquipta offered a substantial decline in mean monthly migraine days from baseline to 12 weeks. The treatment also provided decline from baseline in mean monthly headache days and acute medication days.

This list price of Aquipta is £463.38 for 28 tablets, with the medication set to be made available on the NHS from next month. However, at first it will only be available from specialist doctors in secondary care settings, rather than from GPs.

The US Food and Drug Administration (FDA) first approved the treatment for episodic migraines in September 2021, but AbbVie expanded the drug’s label to include chronic migraines in April 2023. The drug’s European brand name is Aquipta but it is sold under the name Qulipta in Canada and the US. According to GlobalData’s Pharma Intelligence Center, Aquipta is forecast to generate $1.56bn in sales in 2030.

Migraines are intense throbbing headaches, often accompanied by symptoms like nausea, vomiting, and sensitivity to light and sound. Chronic migraines involve experiencing headaches on 15 or more days per month, with at least eight of those headaches meeting the criteria for migraine. Episodic migraines, on the other hand, occur less frequently, typically fewer than 15 days per month. Distinct migraine attacks last four to 72 hours if left untreated. According to GlobalData, the migraine market is set to be worth $18.6bn in 2030 globally.

In June 2023, NICE also recommended Pfizer’s Vydura (rimegepant) to prevent episodic migraine attacks.

https://www.pharmaceutical-technology.com/news/uks-nice-recommends-abbvies-aquipta-to-treat-migraines/?cf-view