AbbVie Submits sNDA to Expand Qulipta (atogepant) Label for Preventive Treatment of Chronic Migraine

Compiled by Fan Dongdong

Recently, AbbVie's Qulipta (atogepant) has achieved another clinical milestone in migraine treatment. Based on the positive results from the Phase 3 PROGRESS trial for chronic migraine, AbbVie plans to submit a supplemental New Drug Application (sNDA) to the U.S. FDA to expand the indication of atogepant for the preventive treatment of chronic migraine.

This trial recruited a total of 778 patients with at least a 1-year history of chronic migraine. Participants were randomly assigned to one of three treatment groups, receiving either once-daily 60mg atogepant, twice-daily 30mg atogepant, or placebo.

During the 12-week trial period, the modified intent-to-treat (mITT) population experienced a reduction of 6.88 and 7.46 migraine days per month after receiving once-daily 60mg and twice-daily 30mg doses, respectively, compared to a reduction of 5.05 days in the placebo group. During the 12-week trial period, the non-treatment hypothesis estimate (OTHE) population experienced a reduction of 6.75 and 7.33 migraine days per month after receiving once-daily 60mg and twice-daily 30mg doses, respectively, compared to a reduction of 5.09 days in the placebo group.

Moreover, the study demonstrated that all secondary endpoints achieved statistically significant improvement in the two efficacy analysis populations treated with once-daily 60mg and twice-daily 30mg doses of atogepant. A key secondary endpoint measured the proportion of patients who experienced at least a 50% reduction in mean monthly migraine days during the 12-week treatment period. In the mITT population, trial results showed that 41% and 42.7% of patients on once-daily 60mg and twice-daily 30mg doses of atogepant, respectively, had at least a 50% reduction in migraine days, compared to 26% in the placebo group. Based on the OTHE population, the proportions were 40.1% and 42.1% for the once-daily 60mg and twice-daily 30mg dose groups, respectively, versus 26.5% in the placebo group.

In addition, the third-stage progress study also showed that the overall safety of atogepant was consistent with the safety results previously observed in the episodic migraine population. The most common adverse events reported in the trial were constipation and nausea, and most constipation and nausea events were mild or moderate, without leading to discontinuation of the drug. No liver safety issues were found with atogepant during the trial. The proportion of patients experiencing serious adverse events was 2.7% for those using a once-daily 60mg dose, 1.6% for those using a twice-daily 30mg dose, and 1.2% for placebo patients.

In September 2021, Qulipta received FDA approval for the preventive treatment of episodic migraine in adults, becoming the first oral CGRP receptor antagonist specifically developed for the preventive treatment of migraine. During a migraine attack, the level of CGRP in the patient's blood increases, and it has been found that CGRP released by the trigeminal nerve system is the "trigger" for migraine attacks, making the CGRP signaling pathway a popular target for research and development in the biopharmaceutical field for treating migraines.

Besides Qulipta, AbbVie's migraine portfolio also includes Botox, a versatile injectable that was first approved for migraine treatment in 2010. Additionally, AbbVie acquired another migraine drug, Ubrelvy (ubrogepant), through its $63 billion acquisition of Allergan. This drug had previously been approved for the acute treatment of migraines with or without aura. AbbVie anticipates that both Ubrelvy and Qulipta will achieve peak sales exceeding $1 billion each. During an investor call last month, AbbVie President Michael Severino stated that the company plans to submit a supplemental application for Qulipta for the prevention of chronic migraines this summer, with an expected decision from the U.S. FDA in the first half of 2023.

Reference Source:

1、AbbVie Announces Positive Phase 3 Atogepant (QULIPTA™) Data for the Preventive Treatment of Chronic Migraine

2、AbbVie Prepares to Seek Supplemental Approval for Migraine Treatment

3、AbbVie touts Qulipta chronic migraine win as Biohaven duel heats up