AbbVie submits new drug application to FDA for migraine prevention
AbbVie declared it has submitted a supplemental new drug application to the Food and drug administration for Qulipta, a preventive migraine cure for grownups.
The submission consists of info from the section 3 Progress demo on Qulipta (atogepant, AbbVie), which, if authorised, would be the initially gepant (oral calcitonin gene-related peptide receptor antagonist) for the preventive treatment method of episodic and serious migraine, the corporation mentioned in a push release.
According to the launch, the 12-week trial evaluated the protection, tolerability and efficacy of oral atogepant in individuals diagnosed with persistent migraine for at minimum 1 calendar year who knowledgeable at least 15 headache times in the 28 times prior to enrollment. Atogepant 60 mg as soon as day by day and 30 mg twice day-to-day satisfied all primary and secondary endpoints, with important reduction from baseline of signify month to month migraine days when compared with placebo.
“Having 1 oral treatment to address equally episodic and continual migraine would be an critical progression for well being treatment suppliers and sufferers,” Michael Gold, MD, the therapeutic location head of neuroscience enhancement at AbbVie, stated in the launch. “This [supplemental new drug application] acceptance would also diversify AbbVie’s migraine portfolio and make it the only company to offer two accredited preventive treatments for those living with chronic migraine.
“No two migraine patients are alike, so having a number of treatment possibilities with one of a kind mechanisms of motion is vital,” Gold said.