Pfizer Inc. (NYSE: PFE), a leading pharmaceutical company in the U.S., has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for Nurtec (rimegepant), indicated for the acute treatment of migraine with or without aura. Rimegepant, developed originally by Biohaven, is the first oral CGRP antagonist to demonstrate positive outcomes in a pivotal study within China.
In this study, patients who received a single oral dose of 75mg of rimegepant achieved the co-primary endpoint of pain and most troubled symptom relief within 2 hours. The medication was found to rapidly alleviate pain and the most bothersome symptoms within 45 minutes, restore normal function within 60 minutes, and eliminate pain within 90 minutes. For the majority of patients, the sustained therapeutic effect lasted up to 48 hours. The drug also showed good safety and tolerability profiles, aligning with previous U.S. clinical trial results.
Rimegepant was first approved for marketing in the U.S. in 2020 for the acute treatment of adult migraine attacks and later gained an additional indication for the preventive treatment of episodic migraines, defined as fewer than 15 migraine attacks per month, a year later. Pfizer acquired Biohaven for USD 11.6 billion in May 2022, thereby integrating the drug into its migraine product portfolio.- Flcube.com
