AbbVie submits new drug application to FDA for migraine prevention
AbbVie announced it has submitted a supplemental new drug application to the FDA for Qulipta, a preventive migraine treatment for adults.
The submission includes data from the phase 3 PROGRESS trial on Qulipta (atogepant, AbbVie), which, if approved, would be the first gepant (oral calcitonin gene-related peptide receptor antagonist) for the preventive treatment of episodic and chronic migraine, the company stated in a press release.
According to the release, the 12-week trial evaluated the safety, tolerability and efficacy of oral atogepant in patients diagnosed with chronic migraine for at least 1 year who experienced at least 15 headache days in the 28 days prior to enrollment. Atogepant 60 mg once daily and 30 mg twice daily met all primary and secondary endpoints, with significant reduction from baseline of mean monthly migraine days compared with placebo.
“Having one oral medication to treat both episodic and chronic migraine would be an important advancement for health care providers and patients,” Michael Gold, MD, the therapeutic area head of neuroscience development at AbbVie, said in the release. “This [supplemental new drug application] approval would also diversify AbbVie's migraine portfolio and make it the only company to offer two approved preventive treatments for those living with chronic migraine.
“No two migraine patients are alike, so having multiple treatment options with unique mechanisms of action is critical,” Gold said.