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Basel, June 2, 2020 — Novartis today announced that it has received notice from the US Food and Drug Administration (FDA) that the agency has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. Regulatory action is now expected in September 2020.
“Novartis will continue to work with the FDA to complete the review as soon as possible,” said Marie-France Tschudin, President, Novartis Pharmaceuticals. “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.”
Additional regulatory filings are currently underway and regulatory approval for ofatumumab in Europe is expected by Q2 2021.
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