Amgen, Sanofi PCSK9 drugs shown to cut CVD risk in half
- Cholesterol-lowering drugs in the highly anticipated PCSK9 class from Amgen and Sanofi/Regeneron cut cardiovascular event risk in about half in phase III trials, Reuters reports.
- Amgen's Repatha (evolocumab) and Sanofi/Regeneron's Praluent (alirocumab) cut the risk of serious cardiovascular events in cholesterol patients from 2.18% to 0.95% and from 3.3% to 1.7%, respectively. Amgen's "events" included death, heart attack, stroke, unstable chest pain or heart failure requiring hospitalization, or the need for a procedure to restore blood flow to the heart, according to Reuters, while Sanofi's "events" included death, heart attack, stroke, or chest pain requiring hospitalization.
- Researchers warned that, while the results are encouraging, more data is necessary before fully gauging this new class of drugs' efficacy. They also noted that rare adverse events such as confusion will have to be closely monitored in ongoing trials.
The race is on between Sanofi/Regeneron and Amgen. But given the promise of the trial results, it seems that these two drugs may be duking it out for a while irrespective of which nabs its FDA approval first.
One big factor will be pricing, as the drugs are expected to be extremely expensive and payers such as Express Scripts have already expressed their intention to seek big deals for these PCSK9 products.