Why the Prasugrel Launch Was Worse Than it Looked: A Sentinel Case Study
This article was originally published in RPM Report
FDA’s new Sentinel system is up and running, and the first examples of real world use of the “real world” post-marketing data network are being showcased. One example of compliance with patient selection criteria for Lilly’s Effient indicates some of the profound ways Sentinel may ultimately reshape regulation—but also suggests that the notoriously slow launch of prasugrel was even worse than it looked.
You may also be interested in...
When FDA took the unusual step of reprimanding a clinical investigator for promoting a newly approved botulinum toxin brand, the agency stressed its over-riding concern about the "first impression" of a new product in marketing messages Commercial sponsors should pay attention: just ask King.
FDA is the first to acknowledge that a lot of things went wrong during the run-up to the prasugrel advisory committee meeting, not the least of which is how the agency handles allegations of intellectual bias among its members. For drug sponsors, it may mean that the rules of engagement have changed.
Lilly is in a race against the clock: it is counting on prasugrel to carve out a blockbuster position in the anti-clotting market before 2011. That is when Plavix generics will complicate the anti-clotting marketand Zyprexa generics will complicate Lilly's outlook. But will FDA go along with Lilly's schedule?