AbbVie filed a supplemental New Drug Application with the U.S. Food and Drug Administration seeking approval for Qulipta for the preventative treatment of migraine.
New NDA has been filed for Qulipta. (Courtesy of AbbVie Inc.)
AbbVie aims to secure another regulatory win for its migraine drug, Qulipta (atogepant). On Tuesday, the company filed a supplemental New Drug Application with the U.S. Food and Drug Administration seeking approval for Qulipta for the preventative treatment of migraine.
Qulipta, a calcitonin gene-related peptide (CGRP) receptor antagonist, won approval from the FDA last year as a preventative therapy for episodic migraine headaches. If approved, Qulipta would be the first gepant with a broad preventive treatment of migraine indication that expands therapy to patients with chronic migraine, AbbVie said.
AbbVie, a leader in migraine treatment, is seeking approval based on the Phase III PROGRESS study that showed the medication could reduce mean monthly migraines. Chronic migraine is defined as an individual experiencing a headache on 15 or more days per month for over three months. During that time, at least eight of the days per month must demonstrate features of a migraine. Data from the PROGRESS study showed Qulipta significantly reduced mean monthly migraine days with both a once-per-day 60 mg dose and twice-daily doses of 30 mg during a 12-week treatment period.
Data showed patients who received 60 mg once per day or 30 mg twice daily saw a decrease of 6.88 and 7.46 monthly migraine days, respectively, in comparison to placebo.
The PROGRESS data also revealed that treatment with both dose levels offered statistically significant improvements in all secondary endpoints for both efficacy analysis populations. When AbbVie announced the data in March, one of the key secondary endpoints included the proportion of patients who achieved at least a 50% reduction in mean monthly migraine days across the 12-week treatment period.
If Qulipta is approved for this indication, AbbVie would be the only company to provide two preventive treatments for those with chronic migraine. In addition to Qulipta, the company’s crown jewel of migraine treatment, Botox is also approved for this indication.
Michael Gold, therapeutic area head for neuroscience development at AbbVie, said the supplemental New Drug Application will diversify the company’s migraine portfolio.
“No two migraine patients are alike, so having multiple treatment options with unique mechanisms of action is critical,” Gold said in a statement.
In addition to Qulipta and Botox, AbbVie’s migraine portfolio also includes Ubrelvy (ubrogepant), which it gained in its $63 billion acquisition of Allergan. Ubrelvy has been approved for the acute (immediate) treatment of migraine with or without aura, a sensory phenomenon or visual disturbance.
In other AbbVie news, the company has terminated a four-year-old collaboration deal with Waltham, Mas.-based Morphic Therapeutic. In 2018, AbbVie and Morphic Therapeutic forged a research and development collaboration to advance Morphic’s oral integrin therapeutics, which are designed to block TGF-β activation in fibrotic diseases. Two years later, that collaboration was strengthened when AbbVie exercised a licensing agreement with Morphic for an αvβ6 integrin specific inhibitor.
However, in a filing with the U.S. Securities and Exchange Commission, Morphic announced AbbVie has walked away from the collaboration. On June 16, AbbVie notified Morphic that it was terminating the agreement “for convenience.” The collaboration will officially end on Dec. 13. In its note, AbbVie said it did not intend to advance any of the selective oral αvβ6-specific integrin inhibitors due to a suspected on-target/ αvβ6- mediated safety signal observed in pre-clinical testing. Featured Jobs on BioSpace
