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Novartis: FDA extends review of B-cell therapy

(CercleFinance.com) - Novartis said on Wednesday that the Food and Drug Administration has extended its review of the company's targeted B-cell therapy ofatumumab for patients with relapsing multiple sclerosis.


The FDA's decision is now expected in September 2020, the Swiss drugmaker said, without specifying the reasons behind the decision.

Novartis said in a statement that it is "well prepared" and ready to launch ofatumumab upon approval. Regulatory approval for ofatumumab in Europe is still expected by the second quarter of 2021.

Ofatumumab is a human monoclonal antibody in development that is self-adminstered by a once-monthly injection, delivered subcutaneously.

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