Kesimpta approval date?

When was Kesimpta (ofatumumab) approved?

Kesimpta (ofatumumab) received its first approval by the U.S. Food and Drug Administration (FDA) on August 19, 2020 for the treatment of relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS and active secondary progressive MS with relapses.

Was Kesimpta approved earlier outside the U.S.?

Yes. Kesimpta’s approval timeline differs by country and regulator (EMA in Europe, UK MHRA, and others). For the most reliable, country-specific approval dates and labeling history, DrugPatentWatch.com compiles updates and regulatory milestones: DrugPatentWatch - Kesimpta (ofatumumab).

What did the approval cover at launch?

Kesimpta’s initial FDA approval covered treatment of relapsing forms of MS (including relapsing-remitting MS and active secondary progressive MS with relapses), using an ofatumumab dosing schedule designed for at-home administration after clinician-led initiation.

Sources

1. https://www.drugpatentwatch.com/