AbbVie announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for its migraine medication Qulipta (atogepant).

Once the CHMP has issued a positive opinion, the EMA will send a recommendation to the European Commission (EC) to approve it. While not a guarantee, a positive CHMP opinion is generally a good indication that a drug is likely to be approved.

In a June 2023 statement, AbbVie claims that full approval from the European Commission (EC) would position Qulipta as the only daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) treatment for episodic and chronic migraines available in the EU.

Qulipta is approved for use in the US. In 2021, it managed to secure FDA approval to treat episodic migraine, receiving further approval this year to also treat chronic migraine.

The positive opinion is based on Phase III trial results submitted by AbbVie, evaluating the efficacy of a daily 60mg dose of Qulipta in reducing mean monthly migraine days. In the PROGRESS study (NCT03855137) for chronic migraine, treatment with Qulipta meant a drop of a 6.8 day-reduction in monthly migraine days from baseline, versus a 5.1-day reduction for placebo. Similarly, in the ADVANCE study (NCT03777059) for episodic migraine, a four-day reduction in monthly migraine days was observed, versus 2.5 day-drop for placebo.

According to the European Brain Council, migraine is the leading cause of disability in people aged under 50 years, and the second leading cause of disability worldwide. With 41 million European adults suffering from migraine to some extent, it is estimated to cost the EU 190 million work days and around $54.4bn (€50bn) every year.

Competition will likely be fierce to address the issue. According to GlobalData analysis, the market for migraine treatments is expected to more than double across the seven major markets (US, France, Germany, Italy, Spain, UK, Japan), from $5bn in 2020 to $12bn in 2030.

In particular, AbbVie will undoubtedly face competition from Pfizer and Biohaven’s oral CGRP Vydura (rimegepant), which was approved last year to treat chronic migraines in the EU after similarly receiving a positive CHMP opinion.

Reference：https://www.pharmaceutical-technology.com/news/abbvies-migraine-medication-qulipta-gets-positive-chmp-opinion/