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The product labels of all JAK inhibitors will be updated to include a precautionary approach for patients aged 65 years or above, those at increased risk of major cardiovascular problems (such as heart attack or stroke), those who smoke or have done so for a long time in the past and those at increased risk of cancer. For those at-risk patients, the recommendation is that JAK inhibitors, including Jyseleca, should be used only if no suitable treatment alternatives are available. The CHMP followed PRAC’s recommendation that JAK inhibitors should be used with caution in patients with risk factors for blood clots in the lungs and in deep veins (venous thromboembolism, VTE) other than those listed above

Galapagos announces CHMP adoption of PRAC’s recommendation for Jyseleca® following extensive ...

Mechelen, Belgium; 11 November 2022, 13.15 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted PRAC’s recommendation to add measures to minimise risk of serious side effects with JAK inhibitors for chronic inflammatory disorders

By Galapagos NV
Published - Nov 11, 2022, 07:24 AM ET
Last Updated - Apr 24, 2024, 01:38 PM EDT
  • Supportive outcome for Jyseleca as treatment option with a positive benefit/risk profile after review of safety data of all JAK inhibitors approved in Europe for treatment of inflammatory conditions 
  • This follows the recommended harmonization of EU labels for all JAK inhibitors by Pharmacovigilance Risk Assessment Committee (PRAC)
  • For patients aged ≥65 years, current or long-time past smokers and patients with a history of atherosclerotic cardiovascular (CV) disease or other CV and malignancy risk factors, risk minimization measures have been adopted
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