Results

Amgen steers PCSK9 blockbuster hopeful through another promising PhIII, but the critical test is looming

Sean Harper, Executive Vice President, Research and Development

Amgen took another step down a long path aimed at outlining the health advantages offered by its PCSK9 drug Repatha. In a Phase III study, researchers for the company said that the drug hit the primary endpoint, significantly reducing the need for a procedure known as apheresis, which is used to counter high LDL levels in certain at-risk patients.

The drug, already approved to control cholesterol, also met secondary endpoints on the percent change from baseline to week 4 in LDL-C, non-high-density lipoprotein cholesterol (non-HDL-C) and total cholesterol: HDL-C ratio.

“Patients who require apheresis to help control their LDL-C have limited treatment options and face the daunting challenge of frequent, invasive and costly procedures,” said Amgen R&D chief Sean E. Harper. “These positive data suggest patients may have an alternative option to help them manage their cholesterol.”

While Repatha and the rival drug Praluent from Regeneron and Sanofi are in use, payers have constructed some high walls around access. They want to see hard data on how these drugs impact health. Amgen scored a huge success recently when it announced that their drug had succeeded in a cardiovascular outcomes study, and analysts are waiting to see the data at the upcoming meeting of the American College of Cardiology later this week.

Analysts are looking for about a 20% reduction in cardio risk as a sign that Amgen can carve out blockbuster success in the market.

In the meantime, the big biotech has squared off against Regeneron and Sanofi in the courts, claiming that their drug violates Repatha patents. And they came close to a knockout blow, forcing the two collaborators to scramble to keep a judge’s order from sidelining their drug.

Right now, Amgen would like nothing better than a monopoly on this market, as Regeneron and Sanofi push ahead on a cardio outcomes study of their own.


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RAPS Regulatory Convergence 2017