FDA rejections signal tougher developers standards

Faced with back [1]-to-back [2] rejections of two would-be blockbuster drugs for cholesterol, analysts have been reading the tea leaves [3] for what this could portend for developers. What they've come up with boils down to a tougher set of standards for cholesterol drugs and a much more skeptical view of me-too drugs [4]. Regulators are increasingly interested in seeing data regarding superior benefits over existing meds. And that will take more time and money to produce.

"The party for all these 'me-too' drugs has been over for at least two years," WBB Securities analyst Steve Brozak told the AP. "It's just that these pharmaceutical companies are only now beginning to realize it."

It seems clear now that the FDA--in the wake of the Vytorin fiasco--will demand data on new cholesterol drugs demonstrating that they can improve outcomes rather than simply influence cholesterol levels.

- check out the AP report [5]

Related Articles:
Merck shares hammered after FDA rejects Cordaptive [1]
Cholesterol drug delay signals new FDA standards [2]
Dry spell or parched desert for NME approvals? [6]
Developers: Politics behind slow approval process [7]