AbbVie Inc said, on Tuesday 28 september, the U.S. health regulator approved its once-daily oral medicine for preventive treatment of migraine in adults, adding a third drug to the drugmaker's arsenal of therapies for severe headaches.

The drug, Qulipta^TM, which AbbVie will launch in early October, will enter a crowded market for migraine prevention drugs such as Eli Lilly's Emgality, Amgen Inc's Aimovig and Biohaven Pharmaceutical Holding Co Ltd's Nurtec ODT.

"Millions of people living with migraine often lose days of productivity each month because attacks can be debilitating. Qulipta^TM can help by reducing monthly migraine days with a once-daily, oral dose that works quickly and continuously," said Michael Severino, M.D., vice chairman and president, AbbVie..

Analysts expect the drug to bring in sales of over $640 million by 2025, according to Refinitiv data.

AbbVie acquired Qulipta^TM in 2020 as part of its $63 billion deal for Allergan, along with anti-wrinkle and chronic migraine treatment Botox and acute migraine drug Ubrelvy.

Qulipta^TM (atogepant) is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for the preventive treatment of episodic migraine. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology, and studies have shown that CGRP levels are elevated during migraine attacks

The Food and Drug Administration's approval of Qulipta^TM is supported by data from a late-stage study, which showed the drug caused a statistically significant reduction in average monthly headache days in patients compared to placebo.

Migraine, characterized by severe headache and other symptoms such as light sensitivity and nausea, affects about 39 million people in the United States, AbbVie said.

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