Tags: Pfizer | arthritis | drug | Europe

Pfizer’s Arthritis Drug Rejected by European Panel

Thursday, 25 Apr 2013 06:57 PM

 Pfizer Inc.’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 Thursday 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 and Johnson & Johnson’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.

Committee’s View

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.

Pfizer shares declined 2.4 percent to $29.53 in extended trading at 5:50 p.m. New York time after the announcement. The shares closed at $30.26 and have gained 32 percent in the past 12 months.

© Copyright 2017 Bloomberg News. All rights reserved.

   
1Like our page
2Share
Companies
Pfizer'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.
Pfizer,arthritis,drug,Europe
305
2013-57-25
Thursday, 25 Apr 2013 06:57 PM
Newsmax Inc.
 

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
MONEYNEWS.COM
© Newsmax Media, Inc.
All Rights Reserved