European Commission has approved AbbVie’s Equipta, as migraine prophylaxis for adult patients, has become the first daily oral treatment in its class to be approved in the European Union for the prevention of both chronic and episodic migraine.

Several calcitonin gene-related peptide (CGRP) antibodies are administered subcutaneously or via intravenous infusion. But patients have a preference for oral treatments, says Dawn Carlson, vice president of neuroscience development. AbbViein an interview with Pharmaceutical Technology. Lundbeck’s the CGRP antibody Vypti (eptinzumab), is administered via intravenous infusion, while Amazon’s Aimovig (erenumab) is injected subcutaneously.

The approval of EQUIPTA is based on the results of two Phase III studies—ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which both met their primary endpoint of a statistically significant reduction in mean monthly migraine days versus placebo. As announced on 17 August,

In the PROGRESS trial, patients in the 60 mg Equipta group experienced a 6.8-day reduction in mean monthly migraine days, while those taking placebo experienced a reduction of 5.1 days. Carlson explains that such a reduction represents a clinically meaningful change in the experience of patients who feel pain not only during the actual migraine attack, but also in the symptoms preceding the attack. She says the study’s secondary endpoints were equally meaningful, including a reduction in headache days and medication use.

Also known as etogapent, Equipta is a CGRP receptor antagonist (Zepant). The US Food and Drug Administration (FDA) first approved the treatment in September 2021 for prophylactic use as an episodic migraine treatment. In April 2023, AbbVie managed Expand drug label For chronic migraine. while the medicine european brand name Aquipta, it is sold in Canada and the US under the name Qulipta.

Carlsson says: “Now that we have the approval, AbbVie is committed to bringing these to patients quickly and we are working with the appropriate country authorities and reimbursement agencies to bring these solutions to life as quickly as possible …but it will take some time.”

According to GlobalData consensus sales forecast, global sales of Aquipta/Qulipta are estimated to be $1.37bn in 2029.

GlobalData’s parent company is pharmaceutical technology,

Beyond the European Union and countries where the drug has already been approved, AbbVie is looking for further expansion.

“We know that migraine is a global disease affecting more than a billion patients, and we are committed to exploring alternatives in other countries. And it’s on a case-by-case basis, but we’re looking at other areas to bring this forward because AbbVie remains committed to finding solutions for migraine sufferers.

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