NEW YORK, N.Y. – Pfizer Inc. said Thursday that the European Union’s committee of medical experts has rejected the company’s drug Xeljanz for patients with rheumatoid arthritis.
The European Medicines Agency committee recommended against approving the drug because its benefits did not sufficiently outweigh its risks, Pfizer said in a statement.
The New York-based drugmaker said it would appeal the decision.
According to Pfizer, the regulators did not believe the drug consistently controlled the disease or reduced joint damage. The company also said the committee raised concerns about infections, holes in the intestines and tumors seen in patients.
The Food and Drug Administration approved Xeljanz for treating rheumatoid arthritis last November.
Shares of Pfizer fell 87 cents, or 2.9 per cent, to $29.39 in after-hours trading, after closing earlier at $30.26.