No early success for Regeneron, Sanofi in PhIII outcomes study for PCSK9 drug Praluent
Christmas is not coming early for Regeneron and Sanofi.
The companies noted early today that they will have to go all the way to the end of their outcomes trial to see if their PCSK9 drug Praluent can deliver the goods in reducing the risk of a major cardio event after failing to find overwhelming evidence of success in its second preliminary review of the trial.
Investigators recruited 18,000 patients with uncontrolled LDL for the big trial, which will need to be positive if they ever expect to open up the market for their cholesterol drug. Payers have dug their heels in on this drug, along with the rival Repatha from Amgen, which just delivered fresh biomarker data to indicate the likelihood of bending the curve on efficacy for an at-risk group of patients.
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