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EMA could follow FDA’s Xeljanz blood clot warning

European agency in step with FDA after safety doubts


The European Medicines Agency has followed the FDA in saying it is analysing new safety data on Pfizer’s blockbuster Xeljanz, after a post-marketing study of the drug showed a 10mg dose could raise the risk of life-threatening blood clots.

Xeljanz is currently approved in both the US and EU for patients with rheumatoid arthritis (RA) and psoriatic arthritis, but at an authorised dose of 5mg, twice daily.

However, Pfizer is obliged to conduct a post-marketing safety study in at-risk patients (50 years and older) and this has produced some worrying results in patients taking the higher 10mg dose.

Those patients taking this dose twice daily had more pulmonary embolisms and were at risk of an increased overall mortality rate than those taking the 5mg dose. Pfizer responded immediately to the signal by transferring patients on the higher dose to the 5mg dose.

Earlier this week the US drugs regulator released a formal warning in response to the results. It says it is now actively examining the trial data and working with Pfizer to better understand the safety signal, its impact on patients, and how the drug should be used.

The agency says it will take appropriate action to ensure patient safety, but for now says its benefits outweigh any risks, and patients should not stop taking the drug without consulting their doctor.

The results aren’t great news for Pfizer and Xeljanz, which has been plagued with safety concerns and modest efficacy data.

It is the first JAK inhibitor drug on the market for imflammatory conditions, offering a more convenient oral formulation compared to injectable rivals.

Now the EMA has responded to an enquiry by Pharma Market Europe saying it is also “assessing the results of the study and will consider what regulatory action is needed”.

An EMA spokesperson said: “The US FDA advice follows results from an ongoing clinical trial in patients with rheumatoid arthritis which showed a risk of blood clots in the lungs and death when a Xeljanz dose of 10 mg twice daily was used.

“In the EU and the US, this dose is higher than the authorised dose of 5 mg twice daily for rheumatoid arthritis and psoriatic arthritis. The higher dose of 10 mg twice a day is only approved for patients with ulcerative colitis.”

The history of the EMA's earlier decisions on Xeljanz is noteworthy: in 2013 the agency rejected the drug on both safety and efficacy grounds for RA use, despite an earlier FDA approval, only giving it the green light in 2017.

The new safety signals could also cast a cloud over the entire JAK inhibitor class at risk, including AbbVie’s blockbuster-in-waiting upadacitinib, currently being assessed by the EMA and FDA.

Xeljanz was approved for patients with ulcerative colitis in both the EU and US last year, but this group of patients wasn’t included in the safety trial.

Article by
Gemma Jones

28th February 2019

From: Regulatory



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