FDA has been delaying approval of Eli Lilly's experimental medication, Prasugrel, amidst concerns about bleeding problems. The company has been awaiting FDA approval since it submitted the highly-anticipated medication for review last December. Prasugrel is a direct competitor of Plavix, and an early clinical trial showed that is was better than the top-selling blood thinner at preventing blood clots. Unfortunately, it seems to come with a higher risk of bleeding, too.
Researchers for Lilly say that the medication is safe as long as physicians are careful not to prescribe it to patients at high risk for bleeding. Those include patients who weigh less than 130 pounds, patients who are 75 years old or older and patients with a history of stroke. Others say the data are not clear enough to determine which types of patients could take Prasugrel safely.
Industry insiders are watching the potential blockbuster drug closely, but it could be months, or even years, before FDA approves the medication if the company does not find a way to reduce the bleeding risk.
- read the Pharmalot blog post