AbbVie's (ABBV) Qulipta Meets Chronic Migraine Study Endpoints

AbbVie ABBV announced that the phase III study — PROGRESS — evaluating its oral calcitonin gene-related peptide (“CGRP”) receptor antagonist, Qulipta (atogepant) — as a preventive treatment for chronic migraine in adults met all primary and secondary endpoints.

Please note that Qulipta received the first FDA approval in September 2021 as a preventive treatment of episodic migraine in adults. The approval was based on positive data from another phase III study — ADVANCE.

The company plans to file a supplemental new drug application to the FDA based on the PROGRESS study data, seeking label expansion of Qulipta to include preventive treatment of chronic migraine. It is also planning to file regulatory applications outside the United States based on data from ADVANCE and PROGRESS studies going forward, seeking approval for Qulipta as a preventive treatment for episodic as well as chronic migraine.

The PROGRESS study evaluated a once-daily 60 mg dose or twice-daily 30 mg dose of the oral drug for a period of 12 weeks in adults with chronic migraine, who experience headache for 15 or more days per month for more than three months and at least eight of these headaches has features of migraine headache.

Data from the PROGRESS study demonstrated that the two dosing regimens of Qulipta led to a statistically significant reduction from baseline in mean monthly migraine days compared to placebo, the study’s primary endpoint. The treatment with the 60 mg or the 30 mg dose of Qulipta demonstrated a reduction of 6.88 and 7.46 monthly migraine days, respectively, compared with 5.05 monthly migraine days for placebo.

While 41% and 42.7% of patients receiving the 60 mg or the 30 mg dose achieved at least a 50% reduction in mean monthly migraine days from baseline, 26% of patients receiving placebo achieved the same.

Shares of AbbVie have gained 10.1% so far this year against the industry’s decrease of 3.1%.

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We note that AbbVie already has an oral CGRP, Ubrelvy, approved for the treatment of acute migraine. The drug generated sales worth $552 million in 2021 and has witnessed strong uptake since its launch in 2020. Qulipta added $183 million to revenues during the fourth quarter of 2021. AbbVie’s Botox is also approved to prevent headaches in adults with chronic migraine.

AbbVie is the only company to offer three products across the full spectrum of migraine treatment, including preventive therapies for chronic and episodic migraine, as well as acute treatment for migraine attacks. A potential label expansion of Qulipta as a preventive treatment for chronic migraine should complement Botox sales in the days ahead.

However, the migraine market is heavily crowded with several anti-CGRP drugs like Amgen’s AMGN Aimovig, Lilly’s LLY Emgality and Teva’s TEVA Ajovy. The anti-CGRP drugs from Amgen, Lilly and Teva’s portfolio are currently approved as a preventive treatment for migraine. Lilly’s Emgality is also approved for treating episodic cluster headache.

While Amgen recorded $317 million in revenues from Aimovig sales in 2021, Lilly’s Emgality generated $557.2 million in sales. Teva reported Ajovy sales of $313 million last year.

Apart from these drugs, several other small biotech companies are also developing or commercializing promising migraine drugs.

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AbbVie currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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