FDA Approves AbbVie’s Qulipta

AbbVie announced that FDA approved Qulipta (atogepant) for the preventive treatment of episodic migraines in adults on Sept. 28, 2021. According to a company press release, Qulipta is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for preventative migraine treatment.

This approval follows a series of studies that tested nearly 2000 patients who experienced 4 to 14 migraine days per month. According to AbbVie, their pivotal Phase IIb/III study demonstrated that patients would experience a 50-100% reduction in monthly migraine days across 12 weeks.

"Millions of people living with migraine often lose days of productivity each month because attacks can be debilitating. [Quilipta] can help by reducing monthly migraine days with a once-daily, oral dose that works quickly and continuously," said Michael Severino, vice chairman and president, AbbVie, in the press release. "We are proud that AbbVie is now the only pharmaceutical company to offer three products across the full spectrum of migraine treatment, which include preventive therapies for chronic and episodic migraine and an acute treatment for migraine attacks."

According to AbbVie, migraines affect more than a billion people worldwide, including 39 million in the U.S alone. They also state that it is the leading cause of disability in individuals under the age of 50.

Source: AbbVie