U.S. FDA extends review of Novartis' multiple sclerosis drug
(Reuters) - The U.S. Food and Drug Administration has extended the review period for Novartis AGâs 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.