AbbVie announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of atogepant for the prophylaxis of migraine in adults who have four or more migraine days per month. If approved, AbbVie will be the only company to offer a once daily oral calcitonin gene-related peptide (CGRP) […]
Eli Lilly and Company announced results of the CHALLENGE-MIG clinical trial of Emgality (galcanezumab-gnlm) and Nurtec ODT (rimegepant orally disintegrating tablet), the first and only trial of its kind comparing two calcitonin gene-related peptide (CGRP) antagonist therapies. Emgality did not meet the study’s primary endpoint, defined as statistical superiority to Nurtec ODT on the percentage of participants achieving a 50% […]
The FDA has approved Qulipta (atogepant tablets), from AbbVie, for the preventive treatment of episodic migraine in adults. The approval of Qulipta was based on findings from the Phase III ADVANCE study, a Phase II/III efficacy, safety, and tolerability study, and a Phase III long-term safety study. In the pivotal Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group ADVANCE trial, 910 […]
BioDelivery Sciences International, Inc. a growing specialty pharmaceutical company dedicated to patients living with chronic conditions, announced that it has completed the acquisition of U.S. and Canadian rights to Elyxyb (celecoxib oral solution) from Dr. Reddy’s Laboratories Limited. Elyxyb is the first and only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults. […]
Impel NeuroPharma, Inc. announced that the FDA approved Trudhesa (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults. Trudhesa was previously known as INP 104. Using Impel’s proprietary Precision Olfactory Delivery (POD ) technology, Trudhesa gently delivers dihydroergotamine mesylate (DHE)—a proven, well-established therapeutic—quickly to the bloodstream through the vascular-rich […]
Recent Comments