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EMA refuses to back Pfizer’s Xeljanz in rheumatoid arthritis

Surprise after approvals in US and Japan

Pfizer Xeljanz tofacitinib tabletsPfizer received a blow yesterday when a key European regulatory advisory committee declined to recommend Xeljanz as a treatment for rheumatoid arthritis (RA).

The Committee for Medicinal Products for Human Use (CHMP), which assesses drugs for the European Medicines Agency, said data from clinical trials did not demonstrate a favourable risk-to-benefit profile for Xeljanz for the treatment of adult patients with moderate-to-severe active RA.

The decision comes as something of a surprise, considering the drug's previous approvals in Japan and US, and puts at risk the blockbuster potential of Xeljanz, which has been tipped for sales of more than $2bn.

Pfizer used the same data from the same multi-study programme for its EMA application as it did for the US FDA, as well as regulatory bodies in Japan and Russia.

This data included information about the relationship between Xeljanz and an increased risk of opportunistic infections, tuberculosis, cancers and lymphoma, although the FDA allowed the drug to be marketed if it carried a boxed warning of these safety risks.

The CHMP has taken a tougher stance on these safety issues, however, claiming that the benefits of Xeljanz were not sufficient enough to counter these risks.

In addition, the Committee said it did not believe that Xeljanz demonstrated a consistent reduction in disease activity and structural damage to a patient's joints.

Pfizer said it intends to appeal the CHMP's opinion and immediately seek a re-examination.

“Each regulatory authority will review and interpret applications individually and different assessments are not uncommon,” said Dr Yvonne Greenstreet, senior VP and the head of the Medicines Development Group for Pfizer Specialty Care.

“The re-examination process will enable us to seek to address the CHMP's questions, and we will continue to work closely with the EMA with the goal of making this medicine available to appropriate patients in Europe.”

26th April 2013

From: Sales



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