EMA's PRAC recommends curbs on Rxing of JAK inhibitors

In a move that may have a significant impact on some big selling drugs, the European Medicines Agency’s safety committee (PRAC) today recommended measures to minimize the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders.

The class of drugs has been under heavy scrutiny since 2021, when the US Food and Drug Administration concluded that JAK inhibitors lead to an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death, the same as the PRAC findings.

As with the PRAC review, the FDA’s findings were foccused on such drugs for the treatment of arthritis and ulcerative colitis medicines, however, the agency’s imposition of Boxed Warnings on several brands has cast a shadow over the whole sector, which covers other indications such as atopic dermatitis and other immune-mediated diseases.