Shots:

• Novartis reported that the US FDA has extended its review of sBLA for ofatumumab (OMB 157) to treat patients with RMS. The company anticipates the regulatory action in Sept’2020
• Novartis works with the US FDA to continue the review for ofatumumab (SC) in RMS- for the approval in the US with expected EU approval in Q2’21. In 2014- Novartis presented P-IIb results demonstrating a reduction in the number of new brain lesions in the first 24 wks. while the Novartis has initiated P-III program for ofatumumab in RMS in August 2016  
• Ofatumumab (SC- once monthly) is a CD20 mAb- targeting CD20 molecule on the B-cell surface and inducing potent B-cell lysis and depletion. The therapy was originated by Genmab and licensed to GSK- later- Novartis gets rights for ofatumumab from GSK in all indications- including RMS- in Dec’2015

Click here to read full press release/ article | Ref: PRNewswire | Image: Twitter