The US FDA approval is based on data from a large-scale clinical programme evaluating the efficacy, safety and tolerability of Qulipta in 2,000 patients with migraine
AbbVie corporate headquarters. (Credit: AbbVie Inc.)
AbbVie has obtained the US Food and Drug Administration (FDA) approval for Qulipta (atogepant), its preventive treatment for episodic migraine in adults.
Qulipta is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist specifically developed for the preventive treatment of migraine.
CGRP and its receptors are expressed in sections of the nervous system, which are related to migraine pathophysiology, and CGRP levels are elevated during migraine attacks.
The drug works by blocking the CGRP through a once-daily dose and is offered in three, 10mg, 30mg and 60mg dose strengths.
The company is planning to commercialise the preventive migraine drug in October this year.
AbbVie vice chairman and president Michael Severino said: “Millions of people living with migraine often lose days of productivity each month because attacks can be debilitating.
“Qulipta can help by reducing monthly migraine days with a once-daily, oral dose that works quickly and continuously.
“We are proud that AbbVie is now the only pharmaceutical company to offer three products across the full spectrum of migraine treatment, which includes preventive therapies for chronic and episodic migraine and an acute treatment for migraine attacks.”
Migraine is a complex disease with recurrent attacks, often characterised by severe, throbbing headache pain, along with extreme sensitivity to light, sound or nausea.
The FDA approval is based on data from a large-scale clinical programme evaluating the efficacy, safety and tolerability of Qulipta in 2,000 patients who experienced four to 14 migraine days in a month.
Also, results from the Phase 3 ADVANCE study, Phase 2b/3 study, and the Phase 3 long-term safety study supported the regulatory approval.
In the ADVANCE trial, all the patients who received Qulipta met the primary endpoint of statistically significant reductions in mean monthly migraine days compared to placebo.
The Phase 2b/3 trial showed that all Qulipta treatment arms met the primary efficacy endpoint of change from baseline in mean monthly migraine days, compared to placebo.
All doses were well tolerated in the ADVANCE and pivotal Phase 2b/3 trials, with adverse reactions including nausea, constipation, fatigue/somnolence and decreased appetite.
ADVANCE study co-author Peter Goadsby said: “This approval reflects a broader shift in the treatment and management paradigm for the migraine community.
“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.
“I’m particularly encouraged by the convenience of the oral daily use of Qulipta, its rapid onset of significant efficacy, and its safety and tolerability as well as its high patient response rates.”