Novartis Announces Acceptance of its Novel Siponimod (BAF312) by the US FDA and EMA

 Novartis Announces Acceptance of its Novel Siponimod (BAF312) by the US FDA and EMA

Novartis Announces Acceptance of its Novel Siponimod (BAF312) by the US FDA and EMA

Shots:

  • The NDA and MAA Acceptance of Siponimod is based on P-III EXPAND study, assessing Siponimod vs PBO in adults with Secondary Progression Multiple Sclerosis (SPMS) evaluating its safety and efficacy
  • P-III EXPAND study results: reduction in risk confirmed disability progression @3mos 21% & @6mos. 26%. Additionally, P-II BOLD study was conducted to evaluate Siponimod 2mg vs PBO in RRMS demonstrating ARR @6mos. (0.20 vs 0.58)
  • The company used review voucher to expedite the FDA’s review process for Siponimod and also received fast track authorization procedure from Swisssmedic, in Switzerland
  • Siponimod is a selective modulator of specific subtypes of the sphingosine-1-phosphate (S1P) receptor

Click here to read full press release/ article | Ref: Novartis | Image: Fortune

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

Related post