Novartis Reports Acceptance of Ofatumumab’s (OMB157) sBLA from the US FDA and EMA to Treat Relapsing Forms of Multiple Sclerosis (RMS)
Novartis Reports Results of QMF149 in P-III PALLADIUM Study for Patients with Uncontrolled Asthma
Shots:
- The approval is based on P-III ASCLEPIOS I and II studies involves assessing of ofatumumab (20mg, SC) vs Aubagio (14mg oral tablets) in 1882 adults with MS between the ages of 18 and 55 years
- The study resulted in reduction in ARR by 50.5% (0.11 vs. 0.22) and 58.5% (0.10 vs. 0.25), Risk reduction @3mos. & 6mos. (34.4% & 32.5%), favorable safety profile, disability improvement at 6 mos., serum levels of neurofilament light chain (NfL), and rate of brain volume loss
- Ofatumumab is an anti-CD20 monoclonal antibody (mAb), self-administered, once-monthly subcutaneous injection in development for RMS with its expected approval in the US and EU in Jun 2020 and Q2’21
Click here to read full press release/ article | Ref: Novartis | Image: Behance