FDA extends review of multiple sclerosis drug ofatumumab
The U.S. Food and Drug Administration has extended the review period for Novartis AG’s multiple sclerosis drug ofatumumab by three months, Reuters reports.
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.
Ofatumumab, also known as Arzerra, is approved as a leukemia treatment.