After FDA, European Agency Limits Use Of Certain JAK Inhibitors Amid Safety Concerns

  • The European Medicine Agency's safety committee recommended that a group of JAK inhibitors for chronic inflammatory disorders be only used in certain at-risk patients if no alternatives are available.
  • Following the FDA's issuance of a safety warning regarding JAK inhibitors, the safety committee of the European Medicines Agency initiated a review in February.
  • That includes patients 65 years and older, those at risk of major heart problems, those who smoke or have extensively in the past, and those at risk of cancer. 
  • The committee says that patients at risk of blood clots in the lungs and deep veins (VTE) should take caution while recommending lower doses for some patients at risk of VTE, cancer, or major heart problems.
  • RelatedFDA Hits JAK inhibitors With Heart Safety, Cancer Warnings: All You Need To Know.
  • European regulators are updating certain labels, including Pfizer Inc's PFE Cibinqo & Xeljanz, Galapagos' GLPG Jyseleca, Eli Lilly And Co's LLY Olumiant and AbbVie Inc's ABBV Rinvoq.
  • European regulators said the decision is based on Xeljanz data and preliminary findings from an observational study of Olumiant.
  • The review confirmed that Xeljanz increases the risk of major cardiovascular problems, cancer, VTE, serious infections, and death due to any cause compared to TNF-alpha inhibitors. 
  • Some JAK inhibitors, such as Novartis AG's NVS Jakavi and Bristol-Myers Squibb Co's BMY Inrebic) are used to treat myeloproliferative disorders. The review did not include these medicines. 
  • The review also did not cover the use of Olumiant in the short-term COVID-19 treatment, which is under EMA assessment.
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