Pfizer Inc. (PFE) and Bristol-Myers Squibb Co.’s new blood-thinning pill Eliquis has had its review by U.S. regulators delayed by three months.
The delay is from additional data the two companies submitted, Bristol-Myers said in a statement last night. The new data is a “major amendment to the application and will require additional time for review,” the drugmaker said.
The medicine will be sold by the two New York-based companies to prevent stroke and embolisms in patients with atrial fibrillation, or an irregular heartbeat. The drugmakers will split sales from the pill, which Tim Anderson, an analyst with Sanford C. Bernstein & Co. in New York, estimates at $2.5 billion a year by 2015.
“A small delay in the approval of Eliquis would not be terribly material to either Bristol-Myers (BMY) or Pfizer in our view, and FDA delays with new drugs are certainly not an uncommon occurrence,” Anderson wrote yesterday in a note to clients, in which he predicted the delay. “However, this could cut into analyst sales forecasts slightly.”
The U.S. Food and Drug Administration now aims to rule on the drug by June 28, Bristol-Myers said in the statement, from a late March deadline. If approved by the FDA, Eliquis will compete with Xarelto, sold by Bayer AG (BAYN) and Johnson & Johnson, and Pradaxa, sold by Boehringer Ingelheim GmbH (BING).
There aren’t plans for the FDA to convene an advisory committee to rule on the drug, according to the statement.
Bristol-Myers rose 1.5 percent to $32.64 at the close of New York trading. Pfizer climbed 1.7 percent to $21.49.
To contact the reporter on this story: Drew Armstrong in New York at email@example.com
To contact the editor responsible for this story: Reg Gale at firstname.lastname@example.org