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Is Lilly's prasugrel safe?
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
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Doubters see big obstacles for Lilly's prasugrel
Comments
By Anonymous | Posted 12:04am | February 24, 2009
Lilly says risk is greater in low weight patients. Does that mean dose is dependent on EACH patients' weight? Should dose be based on the weight of individual patients? How about body mass index? Low weight patients have very little fat. How does this drug do in patients that are overweight as opposed to patients that are not over weight? Would the optimal dose be too hard to calculate for each patient. What is the half life in the human? Is this a big factor? When this is released, doctors will go slow until they feel comfortable using it and then they will increase their use. If they do not do this docs are taking unnecessary risks because the goal is to increase clotting time and that is the risk... increased clotting time. Can the drug effects be reversed with antidote as rapidly as earlier drug?
The demographics of potential patients has to be considered. Were most of patients in the study overweight, older, skinnier etc. than patients who are expected to be using the drug ? Was the study consistent with what you expect to find in practice?
By Anonymous | Posted 1:08pm | June 3, 2009
As large as Lilly is, I am surprised that they did not have a backup dose of 5 mg for initiation in Phase 3 studies. What doses were used in the phase 2b dose ranging? Did they not have a 5 mg in there? If the drug's MOA and PK characteristics arent affected by body weight and BMI(they probably excluded BMI 30); why indicate a potential label restriction flag of body weight?? Just put the approval review on hold and address the issues otherwise you are risking RMP/label restriction.
By Anonymous | Posted 11:10pm | August 26, 2009
I had a st.steel stent placed in my LAD march 2009. was put on Plavix. August 2009, stent closed and a coated stent put in place of the st. steel, now my Doc wants me to start Effient. Should i give the medicated stent a chance and stay with the Plavix????
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