- Sanofi and Regeneron can now match rival Amgen in claiming a heart benefit for their cholesterol-lowering drug Praluent, securing on Friday an expanded approval from the Food and Drug Administration.
- First cleared by the regulator in 2015, Praluent is now OK'd to prevent cardiovascular events like heart attack or stroke in patients with established heart disease — a label similar to what Amgen's competitor drug, Repatha, received in December 2017.
- While neither Praluent nor Repatha has lived up to once lofty commercial expectations, Amgen's has so far emerged as the most successful. It holds a nearly 70% share of the market versus Praluent, according to weekly prescription data from Iqvia cited by Mizuho Research.
About six years ago, both Amgen and the team of Sanofi and Regeneron embarked on expensive clinical trial programs enrolling thousands of patients to prove the cardio-protective benefits of their competing drugs.
While in each case that bet yielded positive study results, the expected commercial payoff has yet to truly materialize.
Amgen's earlier FDA approval for heart benefits has helped Repatha (evolocumab), steadily boosting prescriptions and yielding higher quarterly sales than those of Sanofi and Regeneron.
Yet the story of the PCSK9 inhibitor drug class hasn't been the blockbuster success many predicted when Praluent (alirocumab) and Repatha first launched in 2015.
Both injectable drugs work to lower LDL, or "bad," cholesterol, binding to a protein known as PCSK9. High levels of LDL-C are linked with greater risk of heart disease, making inhibitors like Praluent and Repatha good candidates for delivering a cardiovascular benefit.
The large outcomes studies run by Amgen and Sanofi and Regeneron bore that out. Both drugs yielded modest, but still significant, reductions in the risk of adverse cardiovascular events like heart attack or stroke.
In Sanofi and Regeneron's case, Praluent lowered the relative risk of heart attack, stroke or unstable angina requiring hospitalization by 15% versus placebo in patients with heart disease already treated with statins.
Notably, Praluent was also associated with fewer overall deaths, nominally cutting the risk of all-cause mortality by 15% — a finding Sanofi and Regeneron were quick to tout in announcing the expanded approval Friday.
In recent months, the companies have cut the prices of their respective therapies, aiming to boost patient uptake and secure better insurance coverage.
So far, however, that lower price hasn't led to higher sales — at least for Sanofi, which reported first quarter sales for Praluent that missed Wall Street expectations by a wide margin. Amgen will announce its sales numbers for the first three months of the year on Tuesday.
This year could also see potential competitors move closer to market. Esperion Therapeutics hopes to win approval for its bempedoic acid, while The Medicines Company expects late-stage trial results for its own PCSK9 inhibitor, inclisiran.