Atogepant (Qulipta) became the first oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for migraine prevention to win FDA approval, Monday.
The drug earned a nod for prevention of episodic migraine in adults and became the second gepant approved for migraine prevention. The first, rimegepant (Nurtec ODT), originally was approved to treat acute migraine but snagged an additional indication for migraine prevention earlier this year.
The atogepant decision "reflects a broader shift in the treatment and management paradigm for the migraine community," noted Peter Goadsby, MD, PhD, DSc, of the University of California Los Angeles and King's College London, who received the 2021 Brain Prize for his groundbreaking work in CGRP and migraine.
"Qulipta provides a simple oral treatment option specifically developed to prevent migraine attacks and target CGRP, which is believed to be crucially involved in migraine in many patients," Goadsby said in a statement.
Atogepant has a . Unlike injectable anti-CGRP monoclonal antibodies approved for migraine prevention in recent years -- erenumab (Aimovig), fremanezumab (Ajovy), galcanezumab (Emgality), and eptinezumab (Vyepti) -- atogepant and other gepants are small-molecule drugs that can be taken orally.
An oral CGRP-receptor antagonist is easier for patients, Goadsby noted when he presented data from atogepant's pivotal phase IIb/III trial at the 2019 American Academy of Neurology annual meeting. "It could facilitate, with time, the greater use of this mechanism in primary care," he told 乌鸦传媒視頻. "Primary care doctors will more easily use a medicine that's relatively simple to use and well-tolerated, and that means more migraine patients can get treated."
The FDA's decision was supported by data from the phase IIb/III trial, plus the pivotal phase III study, and a study.
In , participants were assigned to receive a once-daily dose of oral atogepant (10 mg, 30 mg, or 60 mg) or placebo. After 12 weeks, the mean number of migraine days per month dropped from baseline by 3.7 days with atogepant 10 mg, 3.9 days with atogepant 30 mg, 4.2 days with atogepant 60 mg, and 2.5 days with placebo. The most common adverse events with atogepant were constipation (6.9% to 7.7% across doses) and nausea (4.4% to 6.1% across doses).
Fatigue is another seen with atogepant. Patients should notify their healthcare provider if they have kidney problems or are on dialysis, have liver problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed, AbbVie said.
Atogepant tablets will come in three strengths -- 10 mg, 30 mg, and 60 mg -- and should be available in early October.