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

The U.S. Food and Drug Administration has extended the review period for Novartis AG’s multiple sclerosis drug ofatumumab by three months, the company said on Tuesday.

The company did not disclose the reason for the delay and said the regulatory decision is now expected in September, compared with previous expectations for an approval decision by June.

Novartis said it still expects regulatory approval of the drug in Europe in the second quarter of 2021.

The company has been aiming to tap the multiple sclerosis market where rival Roche sells its $4 billion-per-year blockbuster Ocrevus.

Ofatumumab, also known as Arzerra, is approved as a leukemia treatment.

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Meeta Ramnani
Meeta Ramnani
Meeta develops credible content about various markets based on deep research, opinions from experts and inputs from industry leaders. As the managing editor at Smart Industry News, she assures that every piece of news and article adds to the knowledge of decision makers. An avid bike rider, Meeta, is a postgraduate from Indian Institute of Journalism and New Media (IIJNM) Bangalore, where her specialization was Business Journalism. She carries experience from mainstream print media including The Times Group and Sakal Media Group.