AMGN Amgen Inc

By Jonathan D. Rockoff and Betsy McKay 

Researchers found that Amgen Inc.'s new cholesterol-lowering drug Repatha reduced the risk of deaths, heart attacks and strokes by 20% compared with standard treatment with statin drugs, a benefit that the biotech hopes will persuade health insurers to pay the more than $14,500 yearly list price.

Yet the risk reduction, although significant, may still not be enough for health plans to ease the tight restrictions on use of the expensive drug.

Repatha, among the new injectable cholesterol-fighting agents known as PCSK9s, was approved in 2015 after studies showed it cut levels of bad cholesterol. Unclear was whether that LDL-cholesterol reduction also reduced the risk of heart-related events, such as heart attacks and strokes.

Without such evidence, health plans have limited access to Repatha as well as rival drug Praluent, from Sanofi SA and Regeneron Pharmaceuticals Inc., in favor of much-cheaper statins pills.

Amgen said last month that Repatha had met the goals of its study, but released the specific findings only on Friday at a medical meeting.

Results from the Amgen-sponsored trial, which studied 27,564 patients over 2.2 years, confirmed the real-world benefit of adding Repatha to statin treatment and didn't find any risk of serious side effects, Amgen research and development chief, Sean Harper, said.

The study found the addition of Repatha cut the risk of an array of heart-related events by 15% and reduced the chance of stroke, heart attack and death specifically by 20% compared with patients taking only a statin.

Amgen is "very confident," Dr. Harper said, that doctors will view the results as "practice-changing" and incorporate Repatha into their care of patients whose cholesterol remains high despite treatment with a statin or who can't tolerate a statin.

Stephen Kopecky, professor of cardiovascular diseases at the Mayo Clinic in Rochester, Minn., cautiously praised the results. "It really is incredible that the drug could do even more than statins," he said. "But if you look at it, there are still a lot of people having troubles. This wasn't one of these results where you say, 'wow, this is an incredible reduction.'"

He prescribes the drug for patients who can't be helped by statins or other cholesterol-lowering drugs and said he would likely stick with that prescribing pattern. "I'm not sure this is going to change my practice pattern much. We need to be judicious, because of price and because we want patients to remember that it's not just about the drug," he said, noting patient also need to stick to a healthful lifestyle.

Health plans and drug-benefit managers still may not find the benefits sufficient to justify the high price-tag. "Payers may need to see 25% or more" risk reduction before loosening their reimbursement restrictions, Leerink Partners' Geoffrey Porges said in a recent research note.

In making its case to the payers, Amgen may point to the study's finding that the risk reduction improved after giving Repatha six months. After a year's treatment, patients taking Repatha were at a 25% lower risk of heart-related events, Dr. Harper said.

Write to Jonathan D. Rockoff at Jonathan.Rockoff@wsj.com and Betsy McKay at betsy.mckay@wsj.com

(END) Dow Jones Newswires

March 17, 2017 09:14 ET (13:14 GMT)

Amgen (NASDAQ:AMGN)
Historical Stock Chart
From Mar 2024 to Apr 2024

Amgen (NASDAQ:AMGN)
Historical Stock Chart
From Apr 2023 to Apr 2024