EMA Recommends New Measures For JAK Inhibitors After Confirming Serious Risks

The sponsors of five EU-approved Janus kinase inhibitors for inflammatory conditions will have to update their product information to reflect new measures and warnings from the European Medicines Agency.

Drug warning label
The EMA has been exploring side effects associated with certain JAK inhibitors • Source: Shutterstock

The European Medicines Agency has recommended measures to minimize the risk of cardiovascular problems, cancer and other serious side effects associated with five Janus kinase (JAK) inhibitors that are approved in the EU for chronic inflammatory disorders.

The risk minimization measures apply to Xeljanz (tofacitinib) and Cibinqo (abrocitinib), both from Pfizer, and Jyseleca (filgotinib), Olumiant (baricitinib) and Rinvoq (upadacitinib), from Gilead Sciences/Galapagos, Eli Lilly and AbbVie respectively

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

More from Geography