Novartis AG won FDA clearance for the anti-CD20 monoclonal antibody Kesimpta (ofatumumab) in relapsing forms of multiple sclerosis (MS) in adults, with a label that includes clinically isolated syndrome and relapsing-remitting as well as active secondary progressive disease.
Novartis AG didn’t say why the FDA has put off action until September – a delay of three months – on the sBLA for multiple sclerosis (MS) prospect Arzerra (ofatumumab, OMB-157), first cleared in October 2009 for chronic lymphocytic leukemia, but the holdup brought renewed attention to the bustling space, and Immunic Inc. – which held its R&D Day on May 27 – is coming on strong.
Novartis AG didn’t say why the FDA has put off action until September – a delay of three months – on the sBLA for multiple sclerosis (MS) prospect Arzerra (ofatumumab, OMB-157), first cleared in October 2009 for chronic lymphocytic leukemia, but the holdup brought renewed attention to the bustling space, and Immunic Inc. – which held its R&D Day on May 27 – is coming on strong.
While the efficacy of three central nervous system (CNS) drugs awaiting regulatory approvals is not vastly different from currently marketed products, their formulations and methods of delivery, combined with what payers will support, make them formidable players in the multiple sclerosis (MS) and migraine markets.