Amgen Inc.’s (NASDAQ:AMGN) experimental anti-cholesterol drug, evolocumab, was successful in its fifth late-stage trial. The treatment targets a protein called PCSK9 that’s typically associated with high levels of “bad” cholesterol (or, LDL), Bloomberg reports.
The drug, which is part of a new class of injectable medicines targeted towards a market estimated to be worth billions, met its main goal for it’s most recent study, in which it lowered “bad” LDL cholesterol levels compared with a placebo in 329 patients.
The study’s success enables the company to move forward with an application for approval from U.S. regulators, Amgen, which is based in Thousand-Oaks, California, said in a statement, per Bloomberg. Evolocumab’s success also puts Amgen well ahead (six months to a year ahead, in fact) of it’s competitors pursuing similar therapies. Amgen’s closest rival in the same class as evolocumab is a compound being developed by Sanofi and Regeneration Pharmaceuticals, according to Eric Schmidt, an analyst with Cowen & Co. who spoke with Bloomberg.
Schmidt speculates that Amgen’s evolocumab could potentially target as many of 17 million patients in the U.S. and Europe, and analysts have estimated that Amgen could make more than $1 billion in sales of the drug in 2018, and getting to the market ahead of the drug’s competitors could mean even greater profits for Amgen.
Currently, Pfizer Inc. (NYSE:PFE), Roche Holding AG, Merck & Co. (NYSE:MRK), Alnylam Pharmaceuticals Inc., and Eli Lilly & Co. (NYSE:LLY) all have PCSK9 inhibitors under development as well, according to a Reuters report. The PCSK9 inhibitors are a new class of cholesterol drugs in that they work differently from other statins; the newer treatments, like evolocumab, are geared towards patients who can’t tolerate statins or who still have difficulty getting their cholesterol under control with other medicines.
Amgen’s most recent study (it’s fifth late-stage clinical trial) evaluating evolocumab was in patients with familial hypercholesterolemia, a genetic condition that affects approximately one out of every 300 to 500 people worldwide, according to Amgen.
Sean Harper, head of research and development at Amgen, says he sees the drug as a kind of “salvage therapy [for] patients already availing themselves to all available therapy and who a substantial risk of a cardiovascular event,” he said in a telephone interview with Bloomberg. “My race is really getting this to patients as fast as we possibly can. It’s a substantial global unmet need,” he added.