Genmab: Ofatumumab in Relapsing Multiple Sclerosis Gets CHMP Nod

 

• Novartis receives positive CHMP opinion for subcutaneous ofatumumab for adult patients with relapsing forms of multiple sclerosis
• Opinion based on Phase 3 ASCLEPIOS I and II studies

Genmab A/S (Nasdaq: GMAB) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization of subcutaneous ofatumumab for the treatment of relapsing forms of multiple sclerosis (RMS) in adults with active disease defined by clinical or imaging features. Novartis submitted the Marketing Authorization Application for ofatumumab in this indication in January 2020. Ofatumumab is being developed and marketed worldwide by Novartis under a license agreement between Genmab and Novartis Pharma AG.

https://www.globenewswire.com/news-release/2021/01/29/2166784/0/en/CHMP-Issues-Positive-Opinion-Recommending-Ofatumumab-in-Relapsing-Multiple-Sclerosis.html