FDA Sets September Review Date for Novartis’ Multiple Sclerosis Targeted B-Cell Therapy, Ofatumumab

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #actionadate #b-celltherapy #fda #multiplesclerosis #novartis #ofatumumab #sbla

PRICENTRIC BRIEF:
  • The U.S. Food and Drug Administration (FDA) issued a notice to Swiss-based Novartis explaining that the agency has extended its review of the supplemental Biologics License Application (sBLA) for ofatumumab, a targeted B-cell therapy for relapsing multiple sclerosis (MS)
  • The FDA is now expected to make a decision in September 2020
  • This is not the only regulatory finding underway for Novartis’ MS B-cell therapy; additional filings are under examination in Europe, with approval expected by the second quarter of 2021

 

THE DETAILS

WASHINGTON, D.C., The United States – The U.S. Food and Drug Administration (FDA) issued a notice to Swiss-based Novartis explaining that the agency has extended its review of the supplemental Biologics License Application (sBLA) for ofatumumab, a targeted B-cell therapy for relapsing multiple sclerosis (MS).

The FDA is now expected to make a decision in September 2020.

In a press release, Marie-France Tschudin, President, Novartis Pharmaceuticals, said, “Novartis will continue to work with the FDA to complete the review as soon as possible. We are well prepared and ready to launch ofatumumab upon approval. We are committed to the MS community and look forward to bringing this important advancement to patients with MS.”

This is not the only regulatory finding underway for Novartis’ MS B-cell therapy; additional filings are under examination in Europe, with approval expected by the second quarter of 2021.

 

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