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Novartis : FDA Extends Review Period For Multiple Sclerosis Drug

Novartis (NVS) said that the US Food and Drug Administration has extended its review of the Supplemental Biologics License Application or sBLA for ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. Regulatory action is now expected in September 2020.

The company did not disclose the reason for the delay.

The company said it will continue to work with the FDA to complete the review as soon as possible.

Additional regulatory filings are currently underway and regulatory approval for ofatumumab in Europe is expected by the second-quarter 2021.

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