AbbVie’s Aquipta (atogepant) has been recommended by the National Institute for Health and Care Excellence (NICE) as an oral option for preventing chronic and episodic migraines in adults.
Patients who are eligible for the CGRP antagonist will have had at least four migraine days per month and will have received at least three previous preventive treatments that failed.
Affecting around 4.5 million people in England, migraine is a severe and painful long-term health condition that can have a significant impact on daily life.
Chronic migraine is where a person has at least 15 headache days a month, with at least eight of those having features of migraine, while episodic migraine is where a person has fewer than 15 headache days each month.
NICE’s final draft guidance on Aquipta, taken as a once-daily tablet, is expected to benefit 170,000 patients in England and will provide an alternative to CGRP antagonists that are delivered by injection or infusion.
Helen Knight, director of medicines evaluation at NICE, said: “Currently, the most effective options for people with chronic migraines who have already tried three preventative treatments are drugs that need to be injected.
“The committee heard from patient experts that some people cannot have injectable treatments, for example, because they have an allergy or phobia of needles.”
The agency’s decision, which follows the approval of the therapy by the Scottish Medicines Consortium in October, is supported by positive results from three late-stage clinical trials evaluating Aquipta 60mg once daily in adults living with episodic and chronic migraine.
All studies met the primary endpoint of a change from baseline in mean monthly migraine days across 12 weeks with Aquipta treatment versus placebo. Results also demonstrated significant reductions from baseline in several secondary efficacy endpoints, including mean monthly headache days and medication days.
Rachael Millward, medical director, AbbVie UK, said: “Migraine is a complex neurological condition with attacks that are often incapacitating and can include headache pain, nausea, sensitivity to light and sound.”
Millward continued: “The recommendation from NICE means that suitable people living with migraine in England and Wales will have access to an additional treatment option that has the potential to improve their quality of life.”