NORTH CHICAGO, Ill., April 12, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced an interim analysis of an ongoing Phase 3, open-label 156-week extension study evaluating the long-term safety and tolerability of oral atogepant for the prevention of migraine in participants with chronic or episodic migraine. The overall long-term safety results were consistent with the known safety profile of atogepant in chronic and episodic migraine, and no new safety signals were identified. These results also support improvements in key efficacy outcomes, including reduction in monthly acute medication use days.
NORTH CHICAGO, Ill., Aug. 17, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Commission has approved AQUIPTA® (atogepant) for the prophylaxis of migraine in adults who have four or more migraine days per month. The approval makes AQUIPTA the first and only once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) treatment in the European Union for the preventive treatment of both chronic and episodic migraine.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended this week that the European Commission authorize two new treatments for migraine and chronic kidney disease-associated anemia.
Study has been focusing on atogepant for the prevention of episodic migraine attacks
On Tuesday, the Illinois pharma announced the FDA approved an expanded indication of the calcitonin gene-related peptide (CGRP) for the preventative treatment of chronic migraines in adults. Qulipta is a once-daily oral drug initially approved in 2021 for preventing episodic migraines in adult patients.
U.S. FDA Approves QULIPTA® (atogepant) for Adults With Chronic Migraine
EXTON, Pa., March 16, 2023 /PRNewswire/ -- Spherix Global Insights recently released data from their Launch Dynamix™: Qulipta for Migraine Prevention (US) deep dive study tracking the launch of AbbVie's Qulipta for the preventive treatment of episodic migraines. At fifteen months post-launch, analysis reveals that AbbVie's brand has made significant strides over the course of their entry on prescriber perceptions, including increasingly favorable rating for Qulipta awareness, familiarity, use, satisfaction, likelihood to recommend, and the brand's risk/benefit and cost/benefit ratios.
NORTH CHICAGO, Ill., July 18, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for atogepant for the prophylaxis of migraine in adult patients who have at least four migraine days per month. The application is supported by the pivotal Phase 3 ADVANCE and PROGRESS studies evaluating the safety, efficacy, and tolerability of atogepant in adult patients with episodic migraine and chronic migraine, respectively.
NORTH CHICAGO, Ill., June 21, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted a supplemental New Drug Application (sNDA) for atogepant (QULIPTATM) to the U.S. Food and Drug Administration (FDA) to support the preventive treatment of chronic migraine in adults. If approved, atogepant (QULIPTA) would be the first gepant (oral calcitonin gene-related peptide [CGRP] receptor antagonist) approved for the broad indication of the preventive treatment of migraine, including episodic and chronic. The sNDA submission 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.
AbbVie’s Qulipta (atogepant) notched another clinical milestone in the treatment of migraines. This morning, the Illinois-based company announced Qulipta hit the mark in its Phase III PROGRESS study by reducing mean monthly migraine days compared to placebo.