Lilly’s much talked–about cardiovascular drug prasugrel is still without an FDA approval letter, yet the agency has made no mention of the fact that a decision about the drug missed its September 26 deadline, nor has FDA given the reasons behind the delay.
Meanwhile, Lilly and its partner Daiichi Sankyo released a three-paragraph statement acknowledging FDA’s tardiness in approving the drug by the Prescription Drug User Fee Act target date. "We remain engaged in collaborative and productive discussions with the FDA regarding the details of our application,” said Jennifer Stotka, vice president for Global Regulatory Affairs at Lilly, in the statement. “This is a very large, complex submission, and it should not be surprising that delays occur. Daiichi Sankyo and Lilly will not speculate on the timing or what the outcome will be. However, the review is very far along, and we remain optimistic.”
Calls to Lilly for an interview explaining how this delay compares to other drug submissions it has filed in the past were declined. FDA also didn’t respond to requests for more information about the holdup.
The one thing that is certain is that Lilly did not receive a “complete response” letter—FDA’s new communication that signifies that a drug is neither approved nor denied, and lists areas in need of improvement before the drug can be approved. The new guidance went into effect in July, and replaces the often-confusing “approvable” and “not approvable” letters FDA previously sent when a drug was not ready for prime time.
“This has become a bit of an unsettling trend at the FDA,” stated Les Funtleyder, healthcare strategist at Miller Tabak + Co. “The decision tree used to be pass or fail; now there is a third [branch]: ‘I don’t know.’ If the ‘I don’t know’ actually ensures public health it would be one thing, but a really unsuitable drug should just not be approved.’”
In a letter, Funtleyder said that the delay gives Bristol-Myers Squibb and Sanofi-Aventis’ Plavix more time to rule the roost. Lilly’s prasugrel, to be marketed in the US as Effient, will be the first real cardiovascular competition BMS and SA have faced since Plavix launched in 1997.
“In our view, the delay is likely to be rather short, as the FDA is in the late stages of the review, and did not request more data,” stated Deutsche Bank Analyst Barbara Ryan in a letter. “We maintain our ‘hold’ rating on Lilly, as we do not believe that prasugrel will be large enough to offset patent expirations at Lilly in 2011 and beyond.”