Dive Brief:
- The European Medicines Agency has begun a safety review of a group of similarly acting immune drugs from Pfizer, AbbVie, Eli Lilly and Belgian biotech Galapagos, citing data from a clinical trial of one of the medicines that showed a higher risk of heart problems and cancer.
- The review focuses on so-called JAK inhibitors, which block enzymes known as Janus kinases and are approved for inflammatory conditions like rheumatoid arthritis and eczema. While the study results that concerned the EMA involve Pfizer's Xeljanz, an older JAK-blocking drug, the regulator also aims to determine whether the safety risks observed are similarly associated with newer JAK inhibitors.
- The EMA has already updated Xeljanz's labeling to reflect the higher risk of major cardiovascular events and cancer, while, across the Atlantic, the Food and Drug Administration recently put in place new limits on who can take Xeljanz and JAK-blocking drugs like it.
Dive Insight:
JAK inhibitors are a major class of medicines, with more than a half dozen approved for a range of conditions and sizable sales forecasts from their developers to match. Yet concern over the drugs' association with increased risks of major health problems has overhung their market expansion.
Regulators' scrutiny was drawn by results of a large study testing Xeljanz against TNF inhibitors, another widely used drug class that includes medicines like Humira and Enbrel, which showed treatment with Pfizer's drug was associated with high risk of heart attacks, stroke and cancer. Additionally, that study and another testing Eli Lilly's Olumiant indicated risk of blood clots and serious infections.
In the U.S., the FDA now requires those risks to be included on the drugs' labeling and that the drugs be only given to patients who cannot take or do not respond to treatment with a TNF inhibitor.
European regulators, which previously put warnings on Xeljanz's label, now seem to be considering whether to take a similar course. The review by the EMA's safety committee will seek to "determine whether these risks are associated with all JAK inhibitors authorized in the EU for the treatment of inflammatory disorders and whether the marketing authorizations for these medicines should be amended."
Those medicines include Xeljanz, Olumiant, AbbVie's Rinvoq, Pfizer's newer drug Cibinqo and Galapagos' Jyseleca, which isn't approved in the U.S.
Notably, two JAK inhibitors approved to treat myelofibrosis aren't covered by the EMA's review.
"The EMA had historically been more lax on JAK class safety and gave greater leeway to physicians to use the drugs in their patients as they saw fit, versus the FDA which has been slow to approve new indications and much stricter with labeling given cryptic safety signal imbalances," wrote Brian Abrahams, an analyst at RBC Capital Markets, in a Feb. 11 note to clients.
While Abrahams doesn't expect drugs to be withdrawn from market as a result of the review, he indicated the EMA's scrutiny could impact "the relatively open landscape in Europe where the drugs have seen broad adoption across inflammatory indications."
The EMA did not give a timeline for the safety committee's review, any conclusions from which would go to the agency's Committee for Medicinal Products for Human Use for a formal opinion.