AbbVie’s Qulipta has gained an edge in the heated migraine market thanks to a new approval to prevent chronic migraines.
The new FDA nod makes the pill the only oral calcitonin gene-related peptide (CGRP) drug approved to prevent migraines in both the episodic and chronic frequencies, AbbVie said in a Monday statement.
Qulipta's label expansion adds to the drug's 2021 approval for the preventive treatment of episodic migraines. Nearly 200,000 patients have been treated with Quplita since it reached the market, according to AbbVie.
Patients suffer from chronic migraines when they have headaches at least 15 days per month, with at least eight of those being migraines or migraine-associated. Compared with episodic migraines, chronic migraines are more debilitating.
The approval was based off a phase 3 trial that tested the drug over 12 weeks in a once-daily 60-mg form and a twice-daily 30-mg form in patients who've been diagnosed with chronic migraines for at least a year.
In the U.S.-focused patient population, patients in the 60-mg and 30-mg groups experienced a decrease of 6.88 and 7.46 monthly migraine days, respectively, compared with placebo’s decrease 5.05 days. The results were essentially the same on the Europe-focused treatment group.
Trial investigators also sought to determine the proportion of patients who achieved at least a 50% reduction in mean monthly migraine days. In both the U.S.- and EU-focused patient populations, that proportion came out to 41% of patients in the 60-mg group and 42.7% in the 30-mg group, compared with around 26% for placebo.
Qulipta is the third of AbbVie’s migraine treatments, a group that also includes Botox and Ubrelvy. Qulipta is approved at 10-mg, 30-mg and 60-mg strengths. Only the 60-mg dose is approved for the preventive treatment of chronic migraines. The new approval makes AbbVie the only company with three treatments “across the spectrum” of migraines, Chief Medical Officer Roopal Thakkar, M.D., said in a statement.
The company’s chief migraine rival, Pfizer's Nurtec ODT, doesn't carry an FDA approval to prevent chronic migraines. That drug, which beat Qulipta to the market, is approved as a preventive treatment for episodic migraines and as an acute treatment for migraines when they happen.
AbbVie estimates Qulipta's peak sales will reach more than $1 billion. The drug posted sales of $158 million in 2022.