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