Pfizer Inc. (PFE)’s rheumatoid arthritis pill failed to win the backing of European drug regulators, who said the drug already approved in the U.S. isn’t effective enough against the condition.
The European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, recommended that Pfizer’s pill Xeljanz not be approved for sale, the New York-based drugmaker said today in a statement. The drug gained marketing clearance in the U.S. in November.
“Pfizer intends to appeal this opinion and immediately seek a re-examination of the opinion by the CHMP,” the company said. The committee decided the drug didn’t show a favorable risk versus benefit profile, Pfizer said.
Xeljanz inhibits part of the immune system that can cause rheumatoid arthritis. The first of a new type of therapies for the disease, the pill is one of Pfizer’s top new products. If approved in Europe, it may generate sales of $510 million there by 2018, according to Mark Schoenebaum, an analyst with International Strategy & Investment Group in New York. The medicine would compete with AbbVie Inc.’s Humira (ABBV) and Johnson & Johnson (JNJ)’s Remicade.
“Pfizer will appeal, but history teaches that odds are against them,” Schoenebaum said today in a note to clients. More data might help Pfizer on appeal, which may take six months, he said.
The European regulators said the drug didn’t show enough effectiveness in reducing the disease’s activity in the body or slowing damage to joints, even though it improved symptoms, Pfizer said. There were also concerns about side effects including tumors and infections.
The European Commission usually adopts the committee’s advice, though it isn’t required to do so.
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