The FDA has just approved ofatumumab for patients with relapsing MS.
See Novartis’ press release below.
- Ofatumumab delivers powerful efficacy with a favorable safety profile and can be self-administered at home, addressing significant unmet needs for people living with relapsing forms of multiple sclerosis (RMS)1
- Approval based on two Phase III ASCLEPIOS studies demonstrating significant reductions in risk of relapses, confirmed disability progression, Gd+ T1 brain lesions and new/enlarging T2 lesions1
- Ofatumumab may halt new disease activity in RMS patients as shown in a post hoc analysis, with 47.0% and 87.8% of patients treated with ofatumumab achieving no evidence of disease activity (NEDA-3) within the first (0–12 months) and second year (12–24 months) of treatment, respectively2
Due to Novartis’ recent bribery case in the USA they are going to have trouble marketing and promoting this product in the US, which means the anti-CD20 marketing wars are going to be asymmetric.
“For more than a decade, Novartis spent hundreds of millions of dollars on so-called speaker programs, including speaking fees, exorbitant meals and top-shelf alcohol that were nothing more than bribes to get doctors across the country to prescribe Novartis’ drugs,” said acting US Attorney Audrey Strauss for the Southern District of New York.