A rheumatoid arthritis pill made by Pfizer was rejected by European drug regulators, who claimed that the drug is not sufficiently effective in fighting the condition. The denial comes after Pfizer won approval for the drug in the U.S.
The recommendation for denial came from the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP. According to the regulators, the drug from Pfizer improved symptoms of rheumatoid arthritis but did not sufficiently reduce the activity of the disease. The regulators also expressed concern regarding side effects from the drug, including infections and tumors.
"Pfizer intends to appeal this opinion and immediately seek a re-examination of the opinion by the CHMP," Pfizer said.
According to International Strategy & Investment Group in New York analyst Mark Schoenebaum, the decision will reduce around 3 percent from future earnings per share estimates for Pfizer. Shares for Pfizer dropped 2.4 percent to $29.53 at 5:50 p.m. EDT on Thursday April 25. The drop comes after Pfizer rose 32 percent over the past 12 months.
"Pfizer will appeal, but history teaches that odds are against them," Schoenebaum said in a note to clients.
The Pfizer drug, called Xeljanz, works by restricting part of the immune system that can lead to rheumatoid arthritis. It is considered to be among the company's top new products and, if approved in Europe, could achieve sales of $510 million there as by 2018.
Drugmakers have found the rheumatoid arthritis market to be especially lucrative, with over $20 billion in sales annually.
