A Forbes August 2015 article showed in 2008, companies filing applications to sell never-before-marketed drugs, which are referred to by the FDA as “new molecular entities,” faced rejection 66% of the time. In 2015 the FDA rejected only three uses for new chemical entities, and approved 25, an approval rate of 89%. Those numbers come from a new analysis commissioned by Forbes from BioMedTracker, a division of publishing giant Informa that helps investors track events in the pharmaceutical industry.
Eliminating BioMedTracker’s counting of multiple uses for the same drug means FDA approved 23 drugs and rejected 1, Merck ’s anesthesia antidote, Bridion. Again, that means 19 of 20 new drug applications were approved. So in reality, the FDA approval rate is more like 96%.
As far as Rayaldee, The SPA with the FDA active involvement throughout the NDA review process speaks volumes.
As far as a prediction percentage, sorry, I am not in a position to comment.
I will tell you this. Pre 2013 OPKO Rayaldee acquisition from Cytochroma, CTAP101 (Rayaldee) commenced dosing in a Phase I/II clinical trial in 2007. Multiple trials later, all meeting primary efficacy and safety endpoints, Rayaldee showed no adverse effect on serum calcium or phosphorus, the key drivers of vascular calcification. Vascular Calcification is the killer of patients with Chronic Kidney Disease.
With a drug over nine years in the making that met all Phase 3 Primary Endpoints. With no other drugs currently on the market or under development that simultaneously control secondary hyperparathyroidism pre-dialysis patients, and corrects the Vitamin D insufficiency. You be the judge.
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