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AbbVie Submits Supplemental NDA for Qulipta for Chronic Migraine
If approved, Qulipta would be the first oral calcitonin gene-related peptide receptor antagonist with a broad preventive treatment of both chronic and episodic migraine.
AbbVie has submitted to the FDA a supplemental new drug application for Qulipta (atogepant) to support the preventive treatment of chronic migraine in adults. If approved, Qulipta would be the first gepant (oral calcitonin gene-related peptide receptor antagonist) approved for the broad indication of the preventive treatment of migraine, including episodic and chronic.
Michael Gold
“Having one oral medication to treat both episodic and chronic migraine would be an important advancement for health care providers and patients,” Michael Gold, M.D., therapeutic area head, neuroscience development, AbbVie, said in a press release. “This sNDA approval would also diversify AbbVie's migraine portfolio and make it the only company to offer two approved preventive treatments for those living with chronic migraine. No two migraine patients are alike, so having multiple treatment options with unique mechanisms of action is critical.”
AbbVie also markets Botox (onabotulinumtoxinA).
The sNDA submission for Qulipta includes data from the pivotal phase 3 PROGRESS trial in patients with chronic migraine, which supplements the existing data in episodic migraine. People living with chronic migraine experience headaches for 15 or more days per month, which, on at least eight of those days per month, have the features of migraine.
The trial met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared with placebo across the 12-week treatment period in adults with chronic migraine. The trial also demonstrated that treatment Qulipta resulted in statistically significant improvements in all six secondary endpoints. This includes a key secondary endpoint that measured the proportion of patients that achieved at least a 50% reduction in mean monthly migraine days across the 12-week treatment period.
The most common adverse events were constipation and nausea.
The FDA approved Qulipta in September 2021 for the preventive treatment of episodic migraine in adults.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
