European Medicines Agency Reviews Arthritis Treatment by Gilead, Galapagos
August 15 2019 - 5:23PM
Dow Jones News
By Dave Sebastian
Gilead Science Inc. (GILD) and Galapagos NV (GLPG) said Thursday
that its marketing authorization application for filgotinib, a
treatment for rheumatoid arthritis, is being evaluated by the
European Medicines Agency.
The application is based on 24-week data from the treatment's
phase 3 clinical trials that demonstrated improvements in arthritis
signs and symptoms, the companies said.
The EMA is a European Union agency that evaluates and approves
medicinal products for its 28 members as well as Norway, Iceland
and Liechtenstein.
Gilead has announced plans to submit a new drug application to
the Food and Drug Administration for the treatment by the end of
the year.
Gilead said in July it will pay $5.1 billion to boost its stake
in Galapagos and gain rights outside Europe to the Belgian
biotechnology company's treatments in development.
Write to Dave Sebastian at dave.sebastian@wsj.com
(END) Dow Jones Newswires
August 15, 2019 17:08 ET (21:08 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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