Pfizer Inc. said its bid to bring a new rheumatoid arthritis pill to the market has been delayed as much as three months by U.S. regulators.
The decision by the Food and Drug Administration had been expected after New York-based Pfizer said on July 31 it would provide the agency with additional analysis of existing data that may require more time to review. The FDA had been scheduled to decide on approval of the drug, called tofacitinib, by today and now will have until Nov. 21.
“The FDA determined that additional data analyses recently submitted by Pfizer constitute a major amendment to the application and will require additional time to review,” Pfizer said in a statement today announcing the delay.
Tofacitinib is a pill that inhibits part of the immune system that can cause rheumatoid arthritis. If approved, it may generate $2.3 billion in annual sales for Pfizer by 2018, according to an estimate by Seamus Fernandez, an analyst with Leerink Swann & Co. in Boston. It would compete with Abbott Laboratories Humira and Johnson & Johnson’s Remicade.
Pfizer shares fell less than 1 percent to $23.69 at the close of New York trading.