FDA may approve Eli Lilly’s anti-clotting drug

Washington, February 4: Prasugrel, Eli Lilly & Company’s signature anti-clotting drug, Tuesday won the unanimous recommendation of a panel of experts for the U.S. Food and Drug Administration’s approval.

The drug now appears to be the first potential threat to Bristol-Myers Squibb’s Plavix, the world's second best selling drug.

Undergoing its pre-approval reviewing since last January, the drug was critically examined for its associated risk of internal bleeding. However, it was effective in correcting blood clots in patients with acute heart problems.

The unanimous 9-0 recommendation vote is based on the 12-month drug trail on nearly 13,600 people. For every 1,000 patients treated with prasugrel, there were 3 fewer heart-related deaths and 21 fewer nonfatal heart attacks than Plavix. However, for every 24 acute heart troubles the drug treated, it caused 10 bleeding side effects.

Underlining the key area, Dr. Ellis F. Unger, the deputy director of the Division of Cardiovascular and Renal Drugs Products at the Center for Drug Evaluation and Research at the F.D.A, marked, "Prasugrel reaches its maximum anticoagulant effect more quickly than clopidogrel, the drug ingredient in Plavix."

Moreover, while critics had advocated a cancerdefine warning (27 cases of cancer in prasugrel patients compared with 19 in Plavix), the FDA panel rejected it saying, "there was no evidence the drug played any role."

"We feel like we've investigated this issue very carefully, and there's no scientific evidence that prasugrel causes new cancer or makes an existing cancer worse," the panel noted.

But, for its serious bleeding concerns, the drug will face a restricted prescription. The drug is not recommended for patients who already stand a high risk of bleeding or with a history of stroke.

Moreover, a labeling encryption would clearly restrict the use of drug among patients older than 75 or those weighing less than 132 pounds, the drug maker disclosed.

The conservative sales projections for prasugrel (to be marketed as Effient) stand at $150 million in 2009 and $1.5 billion by 2015.

However, Chris Schott, an analyst at J.P. Morgan, calls it bit tougher. "You need a much clearer side-effect profile and labeling to get the broad adoption you have with Plavix." His estimates stand at $10 million for 2009 and $825 million by 2013.