FDA Makes It Formal, Rescinds SPA For Amarin’s ANCHOR Study
This article was originally published in The Pink Sheet Daily
Agency makes clear that triglyceride levels are no longer an acceptable surrogate for reducing cardiovascular risk.
You may also be interested in...
Circumstances of FDA's approval of Sarepta's Exondys 51 approval may give BioMarin reason to appeal the complete response for its Duchenne muscular dystrophy treatment drisapersen – but its high-quality data could preclude success.
SPA can be terminated by 'substantial scientific issue,' FDA tells industry, but notes that it only happens less than one percent of the time.
Surrogate markers for cardiovascular products may be going the way of AbbVie's cholesterol franchise.