Pfizer Inc announced that their new rheumatoid arthritis pill Xeljanz has been rejected by European regulators, citing that the potential benefits are less than the risks of the drug, on Thursday, April 25.
European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) said in the statement they 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.
This drug is approved by countries like United States, Japan and Russia. It is used for treatment of adults with moderate to severe active rheumatoid arthritis. Analysts said that if taken twice a day, it could prove more attractive some patients than other drugs that are given by injection every other week, according to Reuters. The drug blocks molecules called Janus Kinases which are linked to joint inflammation.
The committe has weighted high risks of the side effects including serious infections, gastrointestinal perforations and malignancies that have been observed in trials of the drug.
Pfizer is seeking to appeal to CHMP against the decision and "immediately seek a re-examination of the opinion."
Drugs for rheumatoid arthritis and related diseases bring a lot of earning to the drugmakers with more than $20 billion in annual sales.
ISI Group analyst Mark Schoenebaum said in a note to investors that this rejection will cut about 3 percent from future earnings per share estimates for Pfizer, according to Reuters.
Pfizer shares were down 2.7 percent at $29.45 after a short increase of 1 percent that close $30.26 on the New York Stock Exchange.
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