EMA looks to follow the FDA in limiting use of certain immune-regulating drugs
The new recommendations could further curtail the use of so-called JAK inhibitors, though the restrictions imposed in Europe are less severe than they are in the U.S.
An advisory panel to the European Medicines Agency on Friday recommended limiting the use of a group of inflammatory disease drugs because of an established link to side effects such as heart attack and cancer.
In its recommendation, the committee called for curtailing use of so-called JAK inhibitors in patients who are at least 65 years old, are at increased risk of major heart disease or cancer, or are active or long-time smokers. Among those patients, JAK blockers should only be used if “no suitable treatment alternatives are available,” the EMA’s safety committee, known as PRAC, said in its statement.
The panel also cautioned use of JAK inhibitors in those who have a higher risk of blood clots in the lungs and deep vein thrombosis. Those patients, as well as ones at risk of cancer or heart disease, should receive a lower dose of the drugs, the committee said.
The recommendations, which go to the European Commission for a vote, would apply to Pfizer’s Xeljanz and Cibinqo, Eli Lilly’s Olumiant, AbbVie’s Rinvoq and Galapagos’ Jyseleca, all of which are marketed in Europe.
The committee’s findings are the latest blow against JAK inhibitors, which block enzymes known as Janus kinases that are implicated in inflammation. JAK drugs have been approved for a range of inflammatory disease and were meant to be more convenient alternatives to injectable treatments like Humira. But safety problems that first emerged in testing and then in a large post-marketing study have drawn significant scrutiny from regulators, leading to class-wide restrictions in the U.S. and likely soon in Europe.
Last year, for instance, U.S. regulators significantly curtailed the use of JAK inhibitors in all patients, only allowing their use when TNF inhibitors like Humira don’t work. The recommendation in Europe is less restrictive, but will still further dent sales projections in a meaningful market. In a research note in February, RBC Capital Markets analyst Brian Abrahams noted that the drugs have seen “broad adoption across inflammatory indications” in Europe.
As in the U.S., the two JAK inhibitors that are used to treat myelofibrosis, Novartis’ Jakavi and Bristol Myers Squibb’s Inrebic, won’t be affected by the EMA’s recommendation. The panel’s review also didn’t cover Olumiant’s potential use in COVID-19, for which it’s under review in Europe.
The panel said the product information for each drug will be updated to reflect the new recommendations and warnings.
Published Oct. 28, 2022 Christopher NewmanEditor