Novartis Reports Acceptance of Ofatumumab’s (OMB157) sBLA from the US FDA and EMA to Treat Relapsing Forms of Multiple Sclerosis (RMS)

 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

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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