Companies try to quell rumours on prasugrel

pharmafile | October 17, 2008 | News story | Sales and Marketing Efient, lilly 

Daiichi-Sankyo and Lilly have responded to media speculation around the FDA's make-or-break ruling on their major new drug prasugrel.

The product is a rival to anti-blood clotting blockbuster Plavix, and could one day be a multi-billion dollar earner for the companies.

But concerns about uncontrolled bleeding seen in some patients in trials have delayed its approval, and FDA refusal or heavy restrictions could scupper the drug's commercial chances.

A decision is expected shortly from the FDA, but some media reports say a decision will be delayed once again, and will not arrive until March next year at the earliest.

Such a delay would further erode confidence in the drug's long-term chances, and the companies refuted the report, saying a decision could come at any time.

"The FDA can schedule an Advisory Committee at any time during the review of an application. If one is called, then we will be prepared to participate," said John Alexander, head of R&D at Daiichi Sankyo.

The first indication the companies are pursuing is in patients with acute coronary syndromes (ACS) who are being managed with an artery-opening procedure known as percutaneous coronary intervention (PCI), which is usually followed by the placement of a stent to help keep the artery open.

"Daiichi Sankyo and Lilly are engaged in an ongoing dialogue with the FDA," said Jennifer Stotka, Lilly's head of regulatory affairs.

"We remain confident in the overall benefit-risk profile of prasugrel, and we believe this drug should be approved so that we can bring this valuable treatment option to ACS patients, a population at risk for further cardiovascular events."

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