Galapagos’ Arthritis Drug Approved in EU and Japan Amid US Rejection

The recent EU and Japan approvals of the rheumatoid arthritis drug filgotinib contrast with the FDA’s rejection in August. What does this signal for Galapagos, Gilead, and other biotechs working in inflammatory disease?

For Galapagos and Gilead, it’s been a rollercoaster few months. In August, the FDA decided against approving their drug filgotinib for treating rheumatoid arthritis, an inflammatory disease where the joints swell and become painful. In the last two weeks, though, the drug got market clearance for the same indication from the EMA and the Japanese regulator, the Ministry of Health, Labour and Welfare (MHLW).

Branded as Jyseleca, filgotinib is the first drug from Galapagos to gain market approval, and was one of the main drivers for a €4.5B collaboration deal struck with Gilead in 2019. It’s part of a class of drugs called JAK inhibitors, which first entered the market for rheumatoid arthritis in 2012 with the FDA approval of Pfizer’s tofacitinib.

There are already many drugs available for rheumatoid arthritis such as methotrexate and the antibody drug Humira, but they often aren’t enough to control the disease in many patients.

Many people living with rheumatoid arthritis still face persistent disease symptoms and inadequate responses to currently available therapies,” said Walid Abi-Saab,

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Published on Mon, 05 Oct 2020 15:56:56 +0000 and brought to you by nintex dollars to pounds