+ Regulatory
Robert Hadley | Apr 5, 2017

European Commission OKs Pfizer’s Xeljanz for rheumatoid arthritis treatment

The European Commission (EC) has authorized Pfizer’s Xeljanz oral medication to treat moderate to severe rheumatoid arthritis, which affects nearly 3 million people in Europe.

The drug, typically dispensed as a twice-a-day dose of 5 mg tablets, can now be sold in Europe and can help patients resistant to other forms of treatment, according to a Pfizer announcement.

“This is an important advancement for the rheumatology community as up to one-third of people with rheumatoid arthritis may not achieve a response with current treatments and a number of patients may not sustain a response,” Ronald van Vollenhoven, professor of rheumatology and director of the Amsterdam Rheumatology and Immunology Center, said in the press release.

Eight years of positive Phase III clinical trial outcomes convinced the EC to greenlight the drug for use alongside methotrexate, another drug used to treat rheumatoid arthritis. Xeljanz, a new class of drugs that interferes with inflammation on the cellular level, had been authorized for sale in the United States and 80 other countries, the release said.

Rheumatoid arthritis, which is thought to be an autoimmune disease, causes joint pain and other complications for 18 million people across the globe, according to the release.

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