Approval of Novartis’ ofatumumab delayed by FDA review extension

5th June 2020 (Last Updated June 5th, 2020 09:40)

Review of ofatumumab, Novartis’ multiple sclerosis drug (MS), has been extended by the US Food and Drug Administration (FDA) until September 2020, originally expected to occur this month.

Ofatumumab is a fully-humanised anti-CD20 monoclonal antibody (mAb) currently indicated under the brand name Arzerra as therapy for refractory chronic lymphocytic leukaemia (CLL). The drug is expected to enter the US MS market next year, as well as in the five major European markets of France, Germany, Italy, Spain and the UK, and Japan, in 2022. Read more here.