April 25 (Reuters) - European regulators, citing the risks of the drug compared with its potential benefit, declined to approve marketing of Pfizer Inc’s new rheumatoid arthritis treatment Xeljanz, the company said on Thursday.
Pfizer said it plans to appeal and “immediately seek a re-examination of the opinion” by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
The company said in a statement that the committee considered that treatment with Xeljanz improved the signs and symptoms of rheumatoid arthritis and the physical function of patients, but did not believe that a consistent reduction in disease activity and structural damage to joints had been sufficiently demonstrated.
The CHMP also raised questions about side effects including serious infections, gastrointestinal perforations and malignancies observed in trials of the drug.
Xeljanz is approved in the United States, Japan and Russia for the treatment of adults with moderate-to-severe active rheumatoid arthritis.
Rheumatoid arthritis and related diseases have been one of the most lucrative segments for drugmakers, with more than $20 billion in annual sales.