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Kesimpta FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved August 20, 2020)
Brand name: Kesimpta
Generic name: ofatumumab
Dosage form: Injection
Company: Novartis Pharmaceuticals Corporation
Treatment for: Multiple Sclerosis

Kesimpta (ofatumumab) is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Development timeline for Kesimpta

Aug 20, 2020Approval FDA Approves Kesimpta (ofatumumab) Targeted B-cell Therapy for Patients with Relapsing Multiple Sclerosis
Aug  5, 2020Novartis Announces NEJM Publication of Phase III ASCLEPIOS Trials Demonstrating Superior Efficacy of Ofatumumab in Patients with Relapsing Multiple Sclerosis
May 27, 2020Novartis Announces New Late-Breaking Ofatumumab Data at EAN Underscoring Commitment to Advancing Treatment of Relapsing Forms of Multiple Sclerosis (RMS)

Further information

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