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September 29, 2021

AbbVie obtains FDA approval for oral migraine prevention therapy

The FDA granted approval based on favourable results from a strong clinical programme of Qulipta in nearly 2,000 subjects.

The US Food and Drug Administration (FDA) has approved AbbVie’s oral therapy Qulipta (atogepant) as a preventive treatment for episodic migraine in adults.

Qulipta is the first-ever oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specially created for preventive episodic migraine treatment, the company noted.

The drug hinders CGRP through a once-daily dose and will be made available in the US from the beginning of next month in 10mg, 30mg and 60mg doses.

AbbVie vice-chairman and president Michael Severino said: “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 include preventive therapies for chronic and episodic migraine and an acute treatment for migraine attacks.”

The FDA approval is based on results from a strong clinical programme assessing the efficacy, safety and tolerability of Qulipta in approximately 2,000 subjects who have had four to 14 migraine days per month.

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It also included data from the pivotal Phase III ADVANCE clinical trial, the pivotal Phase IIb/III trial and the Phase III long-term safety trial.

In the multicentre, randomised, double-blind, placebo-controlled, parallel-group Phase III ADVANCE trial, all Qulipta dose arms met the primary goal and showed a statistically significant decline in mean monthly migraine days versus placebo.

Patients receiving 60mg Qulipta for 12 weeks had a 4.2-day reduction in migraine days from a baseline of 7.8.

Furthermore, 56%, 59% and 61% of subjects receiving 10mg, 30mg and 60mg Qulipta, respectively, reported a 50% to complete decline in monthly migraine days versus 29% in the placebo arm.

Migraine is a complex disease with repeated attacks that are commonly incapacitating.

During this month, AbbVie announced a collaboration with Regenxbio to develop and market a potential one-time gene therapy, RGX-314, for treating wet age-related macular degeneration, diabetic retinopathy and other chronic retinal diseases.

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