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FDA accepts AbbVie Atogepant new drug application for preventing migraine in adults

 Last Update: 2021-04-24
 Source: Internet
 Author: User

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On March 30, AbbVie announced that the FDA has accepted Atogepant's New Drug Application (NDA), a research oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the prevention of meeting the criteria for paroxysmal migraine Of adult migraines.

Migraine is a complex chronic disease.

Atogepant NDA is based on a strong clinical project data support.

In the multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase III ADVANCE study, all Atogepant active treatment groups reached their primary endpoint, that is, during the 12-week treatment period, compared with placebo, all doses ( 10mg, 30mg, 60mg) Atogepant statistically significantly reduced the average number of migraine days per month from the baseline level.

In terms of safety, compared with the safety observed in previous trials evaluating Atogepant, no new safety risks have been observed.

Atogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), specially developed for the preventive treatment of migraine.

Reference source: US FDA Accepts AbbVie's New Drug Application for Atogepant for the Preventive Treatment of Migraine

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