April 21, 2024

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AbbVie submits new drug application to FDA for migraine prevention

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AbbVie introduced it has submitted a supplemental new drug software to the Fda for Qulipta, a preventive migraine treatment method for grownups.

The submission incorporates info from the period 3 Progress trial on Qulipta (atogepant, AbbVie), which, if accepted, would be the 1st gepant (oral calcitonin gene-linked peptide receptor antagonist) for the preventive cure of episodic and persistent migraine, the corporation mentioned in a push release.

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According to the launch, the 12-7 days demo evaluated the safety, tolerability and efficacy of oral atogepant in sufferers identified with persistent migraine for at least 1 calendar year who experienced at minimum 15 headache times in the 28 days prior to enrollment. Atogepant 60 mg as soon as daily and 30 mg twice daily satisfied all most important and secondary endpoints, with significant reduction from baseline of imply month-to-month migraine times as opposed with placebo.

“Having one particular oral medicine to address the two episodic and continual migraine would be an important progression for health care companies and people,” Michael Gold, MD, the therapeutic region head of neuroscience enhancement at AbbVie, mentioned in the release. “This [supplemental new drug application] approval would also diversify AbbVie’s migraine portfolio and make it the only organization to offer two permitted preventive therapies for those living with serious migraine.

“No two migraine patients are alike, so possessing numerous cure options with special mechanisms of motion is significant,” Gold mentioned.