AbbVie's oral CGRP antagonist Qulipta receives FDA approval for preventive treatment of migraine

CompilationTom Lee

Recently, AbbVie announced that the U.

The approval of this oral CGRP antagonist is supported by data from a strong clinical program that evaluated Qulipta's efficacy, safety, and tolerability in nearly 2,000 migraine patients who experienced an average of 4 to 14 days per month

In the pivotal multicenter, randomized, double-blind, placebo-controlled Phase III ADVANCE trial, compared with placebo, patients had a statistically significant decrease in the average number of migraine days per month, receiving 60 mg Qulipta within 12 weeks The number of days of headache decreased from baseline to 4.

In the trial, all doses of Qulipta group showed good tolerance

Migraine is a complex disease with recurrent episodes and usually incapacitates people.

Qulipta is an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), originally developed specifically for the preventive treatment of migraine

The approved Qulipta includes three doses of 10 mg, 30 mg and 60 mg, and is expected to be on the market in early October 2021

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FDA Approves QULIPTA™ (atogepant), the First and Only Oral CGRP Receptor Antagonist specifically Developed for the Preventive Treatment of Migraine