The U.S. Food and Drug Administration approved Biohaven Pharmaceutical Holding Company Ltd.’s Nurtec ODT (rimegepant 75 mg) for the preventive treatment of migraine. Nurtec ODT is indicated for adult patients with episodic migraine, e.g. those who experience less than 15 headache days per month.
The U.S. Food and Drug Administration accepted AbbVie’s New Drug Application for atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist for the preventive treatment of migraine in adults who meet criteria for episodic migraine.
A roundup of biopharma news and updates includes Merck and Eisai’s Keytruda-Lenvima combo hitting the mark in a Phase III study for advanced endometrial cancer.
Amgen presented five-year Phase II data in episodic migraines at the Migraine Trust Virtual Symposium showing that the anti-CGRP medication Aimovig helped patients achieve sustained reductions in monthly migraine days.
AbbVie’s investigational migraine drug atogepant significantly reduced mean monthly migraine days across a 12-week course of treatment.
The Food and Drug Administration approved an autoinjector device for Teva Pharmaceuticals USA Inc.’s Ajovy (fremanezumab-vfrm) injection.
Teva Pharmaceutical Industries Ltd.’s anti-CGRP drug fremanezumab hit the target reducing monthly migraine days in a late-stage study.