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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

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September 26, 2008

Prasugrel Today?

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Posted by Derek

I wrote back in the summer about the FDA's delayed decision on Lilly's potential anticoagulant blockbuster Effient (prasugrel). Well, those three months have zipped right by, and the agency is supposed to rule today.

Prediction, for what it's worth: I think the drug will be approved, but with label restrictions for the group(s) that seemed to respond best to it in trials - who may have been. at least partly, the groups that could put up with the associated bleeding the best, too. So no elderly patients, no low-weight ones, and no one with a history of stroke or TIA. That'll cut down the market for the drug, definitely, but not as much as if it doesn't get approved at all, right? I think the FDA will require Lilly to keep a careful eye on how Prasugrel performs in the real world while they wait on the results of the next trial to come in, with a possible label-language change to come at that point.

I'll give that option about a 70% chance. The 30% chance is that they delay things yet again, since the agency has been in a delaying risk-averse mood these days. We'll know soon. This new policy of not issuing those irritating "approvable" letters has made this sort of thing rather more tense, hasn't it?

Comments (6) + TrackBacks (0) | Category: Cardiovascular Disease | Regulatory Affairs


COMMENTS

1. john g on September 26, 2008 4:36 PM writes...

Yes, I agree. My cardio-doctor told me he is not prescribing due to trials reporting bleeding...anywhere in body...or in brain.

Stay with Plavix. He is high prescribing cadio in NY.

JG

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2. vasili on September 26, 2008 4:40 PM writes...

http://www.pharmalot.com/2008/09/the-clot-thickens-fda-delays-lilly-blood-thinner-2/#more-15995

It seems the FDA has delayed the decision again.

Permalink to Comment

3. sourgrapes on September 26, 2008 7:10 PM writes...

Another big pharma that turned you down after SP dumped you?

Permalink to Comment

4. vasili on September 27, 2008 1:41 AM writes...

John G: the use of a more effective antithrombotic agent is associated with a raised risk of bleeding. Plavix has also its own risk but it less efficient.
All in all is a question of dose, multiple dosing tablets may be required depending on patient weight.

But that Prasugrel is more potent, can reduce the number of heart attacks and will be approved, is for sure.

Permalink to Comment

5. pharmagossip on September 29, 2008 10:49 AM writes...

The chief operating officer of Bristol-Myers Squibb said Eli Lilly's rival Effient blood clot preventer will be a "niche" product if approved as the TRITON study found it either harmed or offered no benefit to three types of patients.

Permalink to Comment

6. Syed Raza on October 27, 2008 5:06 AM writes...

Is there a need for another anti-platelet? More potent is not always more safe.There are always two sides of the coin.

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