By Dave Sebastian
Gilead Science Inc. (GILD) and Galapagos NV 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.
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