U.S. FDA extends review of Novartis’ multiple sclerosis drug


FILE PHOTO: The brand of Swiss drugmaker Novartis is pictured on the French corporate’s headquarters in Rueil-Malmaison close to Paris, France, April 22, 2020. REUTERS/Charles Platiau/File Photo

(Reuters) – The U.S. Food and Drug Administration has prolonged the review duration for Novartis AG’s multiple sclerosis drug ofatumumab via 3 months, the corporate mentioned on Tuesday.

The corporate didn’t reveal the cause of the lengthen and mentioned the regulatory determination is now anticipated in September, when compared with earlier expectancies for an approval determination via June.

Novartis mentioned it nonetheless expects regulatory approval of the drug in Europe in the second one quarter of 2021.

The corporate has been aiming to faucet the multiple sclerosis marketplace the place rival Roche sells its $four billion-per-year blockbuster Ocrevus.

Ofatumumab, sometimes called Arzerra, is authorized as a leukemia remedy.

Reporting via Manas Mishra in Bengaluru; Editing via Devika Syamnath


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