The FDA has declared Johnson & Johnson's (J&J) experimental premature
ejaculation (PE) drug dapoxetine "not approvable," dealing a potentially
significant setback to the firm's pipeline, analysts said.
J&J subsidiary Alza did not disclose any details about the FDA's decision, saying only that it received a not approvable letter from the agency regarding dapoxetine. Alza received the letter one day ahead of the dapoxetine user fee deadline. Alza's new drug application (NDA) had been closely watched because there are currently no drugs approved in the U.S. to treat PE, a condition that may affect as many as 25 percent of men worldwide.
Although J&J maintained that it did not anticipate immediate approval of the drug, the FDA's decision caught financial analysts off guard, including Standard & Poor's Equity Research analyst Robert Gold, who called the letter "a significant blow" to J&J's pipeline.
"Although the company says it will address these concerns and continue developing the drug, we are surprised by the FDA action and believe removal of this compound impacts our revenue growth forecast starting in 2007," Gold writes in a recent research note.