Baijian and Alkermes submit new drug application to THE FDA for diroximel fumarate (BIIB098)

recently, Biogen and partner Alkermes jointly announced that they have submitted to the U.SFood andDrug(http://Administration (
FDA(http://( theof the new drug(http://application (NDA)biIB098BIIBIB098 is a new oral fumaric acid drug developed for the treatment of recurrent multiple sclerosis (RMS)BIIB098 developed by Alkermes, has been authorized to Baijian, the drug belongs to the immunosuppressant, 2 times a day orally, belongs to the release form of fumaric monomethylester (MMF) pre-drug, can be quickly converted into MMF in the bodyBIIB098 is an upgraded version of Tecfidera with improved gastrointestinal tolerance, the(http:// of Alkermes is seeking approval for BIIB098 through a 505(b)(2) regulatory approach The drug NDA included data from the critical Phase III clinical study EVOLVE-1, which was conducted in patients with recurrent remission multiple sclerosis (RRMS) and assessed the long-term safety of BIIB098, in which approximately 700 patients were treated with BIIB098 if approved, BIIB098 will be listed under the brand name Vumerity, which is sold by Baijian, a name that has been conditionally accepted by the FDA and confirmed at the time of approval The clinical development of BIIB098 includes the EVOLVE-MS-1 study, a 2-year safety study in patients with RRMS, and a comparative BIIB098-Tecfidera drug dynamics bridging study in addition , Alkermes is conducting a EVOLVE-MS-2 study, a five-week head-to-head gastrointestinal (GI) tolerance study designed to compare biIB098 and Tecfidera tolerance