Novartis: FDA, EMA Accept Filings for Ofatumumab in Relapsing Multiple Sclerosis

Date : 02/24/2020 @ 5:34PM
Source : Dow Jones News
Stock : Novartis AG (NVS)
Quote : 84.85  -0.77 (-0.90%) @ 1:00AM
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Novartis: FDA, EMA Accept Filings for Ofatumumab in Relapsing Multiple Sclerosis

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By Colin Kellaher

 

Novartis AG on Monday said the U.S. Food and Drug Administration and the European Medicines Agency accepted the company's applications seeking approval for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults.

The Swiss drug maker said ofatumumab, if approved, has the potential to become a first-choice treatment for a broad patient population and the first B-cell therapy that can be self-administered at home using an autoinjector pen.

Novartis said the applications are based on Phase III studies in which ofatumumab showed highly significant and clinically meaningful reduction in the number of confirmed relapses, evaluated as annualized relapse rate.

Novartis said it expects U.S. regulatory approval for ofatumumab in June and approval in Europe by the second quarter of 2021.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

February 24, 2020 12:19 ET (17:19 GMT)

Copyright (c) 2020 Dow Jones & Company, Inc.

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