AbbVie's Qulipta Receives FDA Approval for New Indication in Chronic Migraine Prevention

On April 17, AbbVie announced that the FDA approved the expanded indication for Qulipta (atogepant) for the preventive treatment of chronic migraine. This approval makes Qulipta the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the prevention of both episodic and chronic migraine. Chronic migraine is a neurological disease that affects work and daily life, with patients experiencing headaches on ≥15 days per month for more than 3 months, including at least 8 days with migraine features.

Qulipta Expanded Indication to Prevent Chronic Migraine Based on Pivotal Phase III PROGRESS Trial: A Global, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Oral Atogepant for Preventive Treatment of Chronic Migraine. A total of 778 patients with at least a 1-year history of chronic migraine were randomly assigned to three treatment groups receiving either atogepant (60 mg once daily (QD)), atogepant (30 mg twice daily (BID)), or placebo.

During the 12-week treatment period, in the modified intent-to-treat (mITT) population, patients in the atogepant 60mg QD and 30mg BID treatment groups experienced reductions of 6.88 days and 7.46 days, respectively, in monthly migraine days compared to the placebo group. Patients in the placebo group had a reduction of 5.05 days in monthly migraine days (after multiple comparison correction, 60 mg vs. placebo, p=0.0009; 30 mg vs. placebo, p<0.0001).

In the OTHE (non-treatment hypothesis estimation) population, during the 12-week treatment period, patients in the atogepant 60mg QD and 30mg BID treatment groups experienced reductions of 6.75 and 7.33 migraine days per month, respectively, compared to a reduction of 5.09 migraine days per month in the placebo group (after multiple comparison correction, 60mg QD vs. placebo, p=0.0024; 30mg BID vs. placebo, p=0.0001).

Studies show that in the two efficacy analysis populations, atogepant 60mg QD and 30mg BID treatments demonstrated statistically significant improvements across all secondary endpoints.

"Since September 2021, Qulipta has helped patients with episodic migraine prevent migraine attacks and reduce the daily burden of migraines," said Roopal Thakkar, Senior Vice President and Chief Medical Officer of AbbVie. "Now, those with chronic migraine can also rely on Qulipta to significantly reduce their migraine days." "This approval makes AbbVie the only company with three migraine treatments, including Qulipta for the prevention of episodic and chronic migraine; Botox (onabotulinumtoxin A), the first FDA-approved preventive treatment for chronic migraine; and Ubrelvy (ubrogepant), a drug for the acute treatment of migraine."

In 2022, CGRP/CGRPR antagonists steadily climbed by 26% to reach $3.171 billion. Analysts had previously predicted that the migraine market size could exceed $11 billion by 2027, with CGRP/CGRPR-targeted drugs alone reaching $6.5 billion.

As the leading player still布局 CGRP赛道, AbbVie expects both Ubrelvy and Qulipta to reach sales peaks of over $1 billion.

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