FDA Pushes Back Review of Novartis’ Multiple Sclerosis Treatment
The FDA has pushed back a review of Novartis’ ofatumumab for patients with relapsing multiple sclerosis (MS), the company said.
Ofatumumab is a human monoclonal antibody that inhibits B lymphocyte activation. It was granted priority review in February for relapsing MS and an approval decision was expected this month.
Novartis did not give a reason for the delay, but said it now anticipates FDA approval in September. The company said it expects regulatory approval for ofatumumab in Europe by the second quarter of next year.