Money Matters, Simplified.
Blood thinner from Eli Lilly gets FDA nod
by Jamie Anderson - July 11, 2009 - comments
The FDA approval for Effient, the blood thinner from Eli Lilly and Daiichi Sankyo comes with the rider of the ‘Black Box’ warning. This condition may slow down the initial sales of the medicine, but analysts aver that the drug may clock yearly sales of $1.9 billion by 2015
New York, July 11: The Food and Drug Administration (FDA) gave a go ahead to Effient, the highly anticipated blood thinner from the Indiana based Eli Lilly &Company (NYSE: LLY) and Tokyo based Daiichi Sankyo Co. (TYO: 4568)
Effient is likely to pose stiff competition to Plavix, the world's second-best selling medication made by Sanofi-Aventis (Euronext: SAN, NYSE: SNY) and Bristol-Myers Squibb Company (NYSE: BMY).
FDA nod comes after a long delay
The FDA approval for the blood thinner comes after a series of delays during the one-and-a half year review period. The agency wanted to be absolutely sure before giving the nod. Hence it conducted a thorough risk-benefit analysis of the drug.
Tony Butler, an analyst at Barclays Capital said of the delay, “This had dragged on for some time -- I think Lilly needed to get this behind them. Here we are in July of the following year, and finally we have a decision.”
Effient, which was approved in 5- and 10-milligram tablets essentially, prevents dangerous blood clots that can lead to heart attack or stroke. Since it thins the blood, it is not recommended for patients with a history of bleeding, or who are to undergo any surgical procedure.
The drug will be administered to patients with acute coronary syndrome, patients undergoing angioplasty or an operation to repair or unblock a blood vessel.
Dr. John Jenkins, FDA's director of new drugs urged, “Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug.”
Sternest warning required
The FDA approval requires that Effient, also known as prasugrel, must carry a "black box" warning about the drug's potential for "significant, sometimes fatal, bleeding".
According to analyst Les Funtleyder from Miller Tabak & Co, such boxed warning curb sales to a limited extent.
"The FDA has been a lot more liberal with black box warnings than it was in the past, and in a way the black box has lost some of the meaning it had when it was rare," said Funtleyder. "But it still has the ability to somewhat limit sales."
Effient is already being sold under the name “Efient” in Europe since April this year. The drug is likely to erode Plavix’s market share by 20 percent.