- Supportive result for Jyseleca as a treatment option with a positive risk-benefit profile after reviewing the safety data of all JAK inhibitors approved in Europe for the treatment of inflammatory diseases
- This follows the harmonization of EU labels for all JAK inhibitors recommended by the Pharmacovigilance Risk Assessment Committee (PRAC).
- Risk minimization measures were implemented for patients ≥ 65 years of age, current or ex-smokers, and patients with a history of atherosclerotic cardiovascular (CV) disease or other cardiovascular and malignant risk factors
Mechelen, Belgium; November 11th 2022, 1:15 p.m. CET; Galapagos NV ((Euronext &, NASDAQ:GLPG) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of European Medicines Agency (EMA), has adopted Recommendation of the PRAC Add measures to minimise Risk of serious side effects with JAK Inhibitors in chronic inflammatory diseases.
“JAK inhibitors are an important treatment option for patients based on an individual benefit/risk balance and we view this finding as a positive development in supporting the best use of the JAK inhibitor class,” said Dr. Walid Abi-Saab, Galapagos Chief Medical Officer. “Jyseleca is the only 2nd Generation JAK inhibitor with preferential JAK1 inhibition at both approved doses and the ability to treat both RA and UC at the lowest effective dose. We are very pleased with today’s outcome and continue our mission to improve the lives of…
