FDA dropping CVOT requirement for diabetes drugs
Small and medium-sized biotechs could enter diabetes space following FDA decision to drop CVOT requirement
Editor’s note: This story has been updated to reflect details contained in FDA’s guidance.
Twelve years after FDA issued draft guidance that made it exorbitantly expensive to bring a new diabetes therapy to market, the agency will no longer require cardiovascular outcomes trials either pre- or postmarket. That, in turn, could re-open the indication to small-and-medium size biotechs.
On Monday, FDA