When is filgotinib expected to be launched?

Filgotinib (Filgotinib) is an oral small molecule JAK1 selective inhibitor, mainly used to treat moderately to severely active rheumatoid arthritis (RA). It was jointly developed by the Belgian company Galapagos and Gilead Sciences. In September 2020, it was approved for marketing by the EU, UK and Japanese drug regulatory agencies respectively, and is sold in the above markets under the trade name Jyseleca. This drug is considered to be a new generation of targeted therapy after JAK inhibitors such as Tofacitinib. It has strong targeting and relatively low systemic side effects, and has high hopes from many rheumatologists.

Although filgotinib has been successfully launched in many developed countries, it has encountered regulatory obstacles in the United States. Because the FDA questioned the possible impact of the drug on male fertility, filgotinib's marketing application in the U.S. market was rejected. This move also affected its advancement in other countries. So far, the drug has not been officially launched in mainland China, and China's National Medical Products Administration (NMPA) has not disclosed clear approval information, so it is impossible to accurately estimate its specific launch time.

However, considering the large number of people suffering from rheumatoid arthritis in China and the growing demand for new targeted oral drugs, the industry generally expects that filgotinib will launch domestic clinical trials or marketing application processes within the next 1-2 years. Once approved, the drug will bring new treatment hope to Chinese RA patients, especially for patients with poor efficacy or side effects of traditional DMARDs, and will become an important alternative. Patients and medical staff can continue to pay attention to relevant developments from the Drug Evaluation Center of the National Medical Products Administration to obtain the latest marketing information.

Reference materials:https://go.drugbank.com/drugs/DB14845