FDA approves Kesimpta (ofatumumab)

Kesimpta is a subcutaneously injected anti CD20 monoclonal antibody approved for RRMS and active progressive MS.
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NHE
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FDA approves Kesimpta (ofatumumab)

Post by NHE » Thu Aug 20, 2020 3:27 pm

Kesimpta is a patient SC injectable anti CD20 monoclonal antibody version of Ocrevus. It's poduced by Novartis in partnership with Genmab A/S.


U.S. FDA Approves Kesimpta® (ofatumumab) in Relapsing Multiple Sclerosis
PRESS RELEASE GlobeNewswire

Aug. 20, 2020, 07:33 PM

https://markets.businessinsider.com/new ... 21968?op=1

Copenhagen, Denmark; August 20, 2020 – Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of Kesimpta® (ofatumumab) injection for subcutaneous use, for the treatment of relapsing forms of multiple sclerosis (RMS) in adults, to includeclinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Kesimpta is the first B-cell therapy that can be self-administered by patients at home using the Sensoready® autoinjector pen, once monthly after starting therapy. It is being developed and marketed worldwide by Novartis under a license agreement between Genmab and Novartis Pharma AG.

The approval was based on data from the Phase III ASCLEPIOS I and II trials, which investigated the efficacy and safety of monthly subcutaneous ofatumumab 20mg versus once daily oral teriflunomide 14mg in adults with RMS as well as the Phase II APLIOS study, which determined the bioequivalence of the subcutaneous delivery of ofatumumab via a pre-filled syringe and a Sensoready pen in patients with RMS. The results from the ASCLEPIOS studies were presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in September 2019 and were recently published in the August 6, 2020 issue of The New England Journal of Medicine. In December 2019 Novartis submitted the supplemental Biologics License Application (sBLA) for this indication to the U.S. FDA.

“This is a significant day for patients in the U.S. with relapsing multiple sclerosis, who will now have Kesimpta as an efficacious and convenient treatment option. We would like to thank the patients and investigators who took part in the trials that led to this approval as well as Novartis for their collaboration and their dedication, which has made ofatumumab available to an entirely new population of patients in need,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

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Re: FDA approves Kesimpta (ofatumumab)

Post by NHE » Thu Aug 20, 2020 3:32 pm


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