Sanofi and Regeneron’s PCSK9 inhibitor alirocumab—one of a group of antibodies heralded as the next class of cholesterol-lowering agents—has had its day in the Barcelona sun at the European Society of Cardiology over the weekend, where the duo released promising Phase-III results from five clinical trials.
At the same time, a survey conducted by Leerink and issued this morning indicates that, while analysts expect these drugs to be blockbusters, awareness among doctors is low, and those physicians who are familiar with the drugs fail to see a clear difference between the two frontrunners, Sanofi/Regeneron’s alirocumab and Amgen’s PCSK9 evolocumab. Alirocumab showed results in line with what’s been seen with evolocumab, which was submitted to the European Medicines Agency today for evaluation and to the FDA last week.
Over 24 weeks, alirocumab boasted a 61% LDL-cholesterol reduction in patients with high cholesterol or the genetic disorder HeFH. After 52 weeks, researchers observed reductions of 57% from baseline levels with 81% of patients overall achieving their pre-defined cholesterol-lowering goals in the trial.
Leerink analyst Seamus Fernandez tempered his excitement for the news, cautioning in a note to investors this morning that the cardiovascular outcomes data are still unclear. “Results of the four ODYSSEY studies including the long-term safety study warrant incremental enthusiasm…yet fall short of instilling confidence that the ODYSSEY outcomes will definitively translate into a cardiovascular event benefit.”
Outcomes data could very well inform the drug’s approvability in Europe’s strict regulatory environment, but will likely have little effect on its submission in the US. An FDA deputy director of drug evaluation and research, Eric Colman, told Bloomberg last November that PCSK9 inhibitors will only have to demonstrate their ability to lower cholesterol and reduce blood pressure—not that they can reduce the risk of heart attack or stroke as well.
PCSK9s are expected to find a lucrative niche in cardiologists’ repertoire, according to Leerink. The investment firm currently forecasts evolocumab and alirocumab to each achieve $4.3 billion in peak sales.
A MEDAcorp survey of 100 US doctors (endocrinologists, primary care physicians, and cardiologists)—conducted for Leerink—found that approximately half of the surveyed physicians “were still unfamiliar with evolocumab and alirocumab including 73-80% of primary care physicians,” and “a large majority of surveyed physicians view evolocumab and alirocumab to be similar and undifferentiated.”
Doctors polled in that same survey also estimated that 45% of their patients do not achieve LDL cholesterol levels below 100 mg/dL, but only “consider 21% of statin-treated patients to have inadequate LDL reduction, who may warrant a new non-statin therapy,” showing a clear disconnect to how doctors perceive high cholesterol and how apt they are to treat it.