Alfasigma announces the Completion of Marketing Authorisation Transfer for Jyseleca® in the European Union

Alfasigma S.p.A. today announced the completion of the transfer of marketing authorization of Jyseleca® (filgotinib) from Galapagos NV (Euronext & NASDAQ: GLPG) to the Italian pharmaceutical company in the European Union.

The marketing authorization transfer was approved by the European Commission following a positive opinion from the European Medicines Agency (EMA) on 2nd August 2024.

This update follows the transaction completed on 31st January 2024 in which Alfasigma acquired the Jyseleca® (filgotinib) business from Galapagos. With this acquisition, Alfasigma consolidated its commitment to specialty pharmaceuticals, adding an innovative product to its portfolio in the gastrointestinal and rheumatological therapeutic areas, that addresses very important patients’ unmet needs.

Jyseleca® (filgotinib) is a once-daily oral JAK1 preferential inhibitor, a class of drugs with an innovative mechanism of action and already approved for two indications: Rheumatoid Arthritis (approved in 2020) and Ulcerative Colitis (approved in 2021).

Furthermore, Alfasigma Group enhanced its presence in the European markets with the acquisition of Jyseleca®, and expanded in the Northern European markets: today Alfasigma Group has branches in Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden, Switzerland, and the UK.