Novartis: FDA, EMA Accept Filings for Ofatumumab in Relapsing Multiple Sclerosis
February 24 2020 - 12:34PM
Dow Jones News
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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