Pfizer’s Xeljanz knocked back by European regulator

Markus MacGill

pharmaphorum

The European Medicines Agency’s adviser the Committee for Medicinal Products for Human Use (CHMP) does not recommend Pfizer’s Xeljanz (tofacitinib) for marketing approval.

Pfizer stands by its rheumatoid arthritis drug and says it will appeal against the decision. Xeljanz is already approved for use in the US and other countries but the European adviser feels its benefits are outweighed by its risks of side-effects such as infection and gastrointestinal perforation.

“We have confidence in Xeljanz and believe our application to the EMA demonstrates that Xeljanz has a favourable risk-to-benefit profile. Xeljanz’s safety profile is well-characterised, and the issues raised by the EMA, including serious infections, gastrointestinal perforations and malignancies, are familiar to rheumatologists who are experienced working with treatments for patients to manage this difficult disease.”

Dr Yvonne Greenstreet, senior vice president and head of specialty care medicines development group, Pfizer

Pfizer’s New York stock exchange share price took a dip on the news.

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Related news:

Pfizer arthritis drug rejected by European regulators (Reuters)

CHMP stuns Pfizer with rejection of RA drug Xeljanz (Pharma Times)

Reference links:

Pfizer press release

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