Lilly Advertises "Effient" Despite Lack of FDA Approval

Eli Lilly is advertising its new blood-thinner, Effient, even though it is not yet approved in the U.S. The drug (also known as prasugrel) is approved in Europe as “Efient,” but ads in which the drug’s name is spelled with two f’s have appeared on the cardiologytoday.com web site. “Effient” appears to be the brand name Lilly is seeking in the U.S.

Clicking on the ads (pictured) takes users through to the Lilly.com homepage — where there is no information about Effient. It is, of course, against FDA regulations to promote a drug that has not been approved. The ad makes no medical claims for the drug. “Coming soon” ads are allowed by the FDA, so Lilly’s ad is technically legit.

This is not the first time Lilly has advertised prasugrel/Effient/Efient before it was approved. Mike Huckman of CNBC saw an Effient banner on the NE Journal of Medicine home page back in September — long before it was approved on either continent.

Of course, Lilly is not alone in its desire to soften up the market before it actually has a product to sell. Sanofi-Aventis had its reps chatting with doctors about cannabinoid receptors way before Acomplia was approved by the FDA (and, ultimately, it wasn’t).

The ads are the latest controversy surrounding the Effient approval process. Lilly suffered some pr damage when it emerged that it had lobbied the FDA to exclude a scientist critical of the drug. The FDA recently admitted the exclusion was a mistake. The drug looks headed for approval anyway.

• See BNET’s previous coverage of Eli Lilly and prasugrel:
• FDA’s Prasugrel Machinations Seem Bound to Attract Doubt
• Lilly CEO Lechleiter’s Prasugrel Bet Appears to Pay Off
• Odds Improve for Lilly’s Prasugrel-ImClone Gamble
  
• In Light of Prasugrel Delay, Lilly-ImClone Deal Suddenly Makes Sense
  
• A Lilly-ImClone Deal May Offer the Drama that CEO Lechleiter Craves