Worth reading that FDA EMAC meeting document referenced in the previous post. Particularly the comments of Dr. Vahle, the Lilly toxicologist, and Dr. Kuijpers, the FDA reviewer of preclinical data, and Dr. Lurie. The pit bull of the committee, appropriately enough, was a Dr. Bone.
The take home message: the rat studies are inconclusive, as they are not the best model. The primate studies are still going (three year follow up), and while they are a better model in that their skeletal physiology is much closer to ours, they are likely to be too underpowered to find the small expected signal of osteosarcoma. Ditto post marketing studies. It could be years to conclusively say one way or the other. The risk was sufficient that the committee voted no for men.
I can see why Peter and others have said that the NPS rat data are probably insufficient to avert a black box warning. Still, the results of the TOP study in humans should be fine. It's the EMAC meeting for PREOS that will be defining, IMO. Worth looking out for the briefing documents, when the time comes. Next I need to look at Forteo's sales data.
However, I wouldn't expect a huge difference between the two drugs, so it seems like a marketing war in which Preos has a slight edge. It will take a partner with the right sales infrastructure already in place, IMO, and I want NPS to partner this.
Cheers, Tuck |
