Lilly’s Prasugrel Is Granted FDA Priority Review
8 CommentsBy Ed Silverman // February 21st, 2008 // 5:11 pm
Less than a week after speculation rose that Lilly’s bloodthinner may be in trouble, the drugmaker crows that the agency has, after all, granted prasugrel a six-month priority review. The new drug application for prasugrel was submitted to the agency on Dec. 26, and as you know, a priority designation by the FDA sets the PDUFA, or Prescription Drug User Fee Act date.
Just last week, Tim Anderson, a securities analyst at Sanford Bernstein, noted that the drugmaker was silent about a priority review, even though Feb. 8 was the date by which the agency was expected to have conveyed its decision. Although he viewed such a development as a “small negative,” he did suggest the lack of a priority review could mean the FDA has concerns with the blood thinner.
You may recall that, two months ago, Lilly released a study found that prasugrel can lower the risk of cardiovascular death, non-fatal heart attacks or non-fatal strokes when compared with Plavix. But the med caused some patients to experience a statistically significant increase in major bleeding compared to those treated with Plavix, the $7 billion gorilla of blood thinners. Overall, for every 1,000 people treated with prasugrel compared to Plavix, there were 23 fewer heart attacks and an additional six major bleeding complications.
UPDATE: On Friday morning, Anderson issued a new investor note to say: “We still believe the FDA may want to put prasugrel before an Advisory Committee of experts. The first such meeting of the Cardiovascular and Renal Drugs Advisory Committee is not until late June (at least per the tentative FDA schedule) but this could be pulled forward. Alternatively, if LLY/Daiichi-Sankyo have communicated their willingness to take a narrow and restrictive label for prasugrel, FDA may feel that there is not enough controversy to warrant an Advisory Committee.”
Matt
Who cares what Lilly has to say about it’s own drug? Their obviously going to be biased and present only evidence that supports the use of their latest wonder drug.
You can bet Lilly pulled some strings through financial ties to the FDA to get a priority review…
Matt
Err… they’re not their
Ed Silverman
Hi Matt,
Well, prasugrel is of interest for a couple of reasons. For investors and industry rivals, an approval is a potentially big deal, because the blood thinner would compete in a huge market and Lilly, like other big drugmakers, needs new big sellers as patents expire on older drugs.
Then, there was the question about whether the drug would pass muster with the FDA, given the recent study results, which were very disappointing after expectations were so high. Even if approved, questions may remain about its utility. And after those well-publicized study results, Lilly was on the defensive. So that’s why I wrote what I did about their announcement today.
Just a little extra context. Hope that helps. And thanks for stopping by.
Cheers
ed
Doc
Competition for Plavix will be good for patients.
Nathan
This last sentence you wrote sums up why drug discovery is so difficult:
“Overall, for every 1,000 people treated with prasugrel compared to Plavix, there were 23 fewer heart attacks and an additional six major bleeding complications.”
This is a conundrum — what do you do? The drug clearly helps some people, but it clearly hurts other people. We don’t know which group a particular individual will fall into. Rest assured, if the drug is approved, a black-box warning will go on the side of the package warning of the major bleeding complication — yet Lilly will get sued for $50 million. That’s what people do here….
ol cranky
What you do is take a look at the commonalities between the subjects who received benefit to limit your indication to that group and look at those who did not to see if you can include more specific safety precautions (i.e, those with a h/o hemorrhagic stroke).
This is a similar problem to drugs in which there is a known or suspected pharmacogenetic component to safety and efficacy. The companies know collecting and analyzing the data to help them identify specific populations that will be responders is likely to identify those that have a potential for increased risk. This narrows the target population and, therefor, the sales so companies are hesitant to evaluate this information (even more so prior to launch). We’re talking about an industry that finds any way to increase sales and create blockbusters, so the lawsuits and settlements are just the cost of business since the profit margin is still higher with these than it would be if they limited the patient population.
Outside the Box
When asked, a majority of physicians said they would take the lower heart attack rate over the higher bleed rate which is not surprising given that a higher proportion of heart attacks lead to death. This is a perfect example of where the new post-marketing surveillance approved in the FDA bill of last year comes in. Identifying common characteristics among populations as small as 6-in-1000 is exactly what that post-marketing scheme is designed to do. Let’s not keep a life-saving drug off the market, but let’s also make sure that we monitor it very closely.
ol cranky
We also need to reinforce to HCPs that is is their obligation to play their part in post-marketing surveillance. I fear that too many see filing MedWatch reports as an inconvenience (at best). Having battled investigators to constantly reinforce the need to report all AEs in clinical trials, I am sure that a significant amount of potential adverse drug reactions go unreported.