After months of delays, Eli Lilly and Daiichi Sankyo finally have word on the status of their anti-clotting drug prasugrel. An FDA advisory committee released a hefty briefing on prasugrel, ahead of a meeting of cardiology experts scheduled for next week. Buried deep in that report is the one sentence that likely comes as music to Lilly and Daiichi's ears: "The Division recommends approval of prasugrel for reduction of myocardial infarction in patients with ACS who are managed with PCI."
The FDA reviews, medical experts from different divisions within the agency, backed prasugrel for heart patients undergoing the percutaneous coronary intervention (PCI) procedure to open clogged arteries, which is usually followed by the stent.
Prasugrel is designed as a therapy for patients with acute heart problems, such as heart attacks, who are at an increased risk for blood clots. In a 12-month study of 13,608 patients, prasugrel outperformed Sanofi-Aventis and Bristol-Myers Squibb's blockbuster Plavix, reducing the number of heart attacks. Although it outperformed a top competitor, analysts continued to express mixed feelings about the potential for FDA approval as prasugrel was also found to increase the risk of bleeding.
Well, according to the FDA, the benefits far outweight the risks. The committee said prasugrel's drug's effectiveness Plavix "seems beyond question" and that data presented a "worthwhile risk-benefit profile for patients who might receive prasugrel." Although the bleeding risk cannot be eliminated, the panel suggested that the risk can be reduced by restricting the drug to patients with a history of stroke and those 75 years old and younger.
The agency also found more reports of cancer within the prasugrel group, but there was no clear indication that prasugrel played a role. The internal bleeding side effects may have led to more medical exams and higher detection of cancers, the agency said. However, the committee recommended that a cautionary note about the increased rate of cancer be included in the drug's label and the risk examined in post-market studies.
The FDA panel's decision is key for Lilly's financial outlook as net sales were essentially flat last year. Not only did Lilly see a 10 percent drop in sales for its blockbuster Zyprexa, but it took a $1.4 billion charge to settle off-label marketing claims. An EMEA committee also recommended approval of prasugrel last month.