Pharmaceutical giant's FDA application for blood thinner, a product that would challenge Bristol's and Sanofi's drug, will take another three months.
INDIANAPOLIS (AP) -- Eli Lilly and Co. said late Monday the Food and Drug Administration will take an extra three months to review its application for the blood thinning drug prasugrel.
Lilly (LLY, Fortune 500) and its Japanese partner Daiichi Sankyo Co. are aiming to gain approval of prasugrel to treat patients with acute coronary syndromes, such as heart attacks or unstable angina, who are at risk of developing blood clots.
If approved, prasugrel would compete against the blockbuster Plavix, made by Bristol-Myers Squibb Co (BMY, Fortune 500). and Sanofi-Aventis SA. (SNY)
The agency is now slated to rule on the application by Sept. 26.
Lilly also said it has started a head-to-head trial of 10,000 patients comparing prasugrel against Plavix.
Goldman Sachs analyst James Kelly said he isn't surprised the FDA sought more time to review the drug's application, given the large amount of data from prasugrel's pivotal late-stage Triton Timi 38 trial, which included over 13,000 patients.
In a note to clients late Monday, he said he continues to expect the drug to be approved, with launch in mid-2009.
Deutsche Bank-North America analyst Barbara Ryan also wasn't surprised at the delay, due to the data's complexity and also the need to define both the drug's target population and risk profile.
"Specifically, prasugrel demonstrated clear benefits in the primary endpoint -- 12 month MACE vs Plavix, the standard of care -- but also carries a clear higher risk of severe bleeds, making this a tough call for FDA," she wrote in a note to clients.
Acute coronary syndromes affect 1.4 million people in the U.S. every year.
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