- The Food and Drug Administration handed Amgen Inc. an early December bonus, granting approval of the biotech's cholesterol drug Repatha for prevention of heart attacks, strokes and coronary revascularizations in adults with established cardiovascular (CV) disease.
- Approval should give Repatha a competitive edge against rival PCSK9 inhibitor Praluent and help to boost sluggish sales. The FDA also cleared Repatha to be used as an adjunct to diet to lower LDL-C in patients with primary hyperlipidemia.
- The FDA's decision had been expected after Amgen's FOURIER study showed treatment with Repatha lowered the risk of major adverse cardiovascular events by 15%, and a narrower composite of CV death, heart attack or stroke by 20%.
Uptake of Repatha (evolocumab) has remained slower than expected, due in part to payer pushback against the relatively high cost of the drug — around $14,000 a year at list price.
Still, sales are growing and Amgen hopes the new CV label can help buoy them further. The American College of Cardiology's recent inclusion of Repatha's cardiovascular outcomes data into its consensus decision pathway for LDL-cholesterol lowering should also help.
For its part, Amgen remains positive. CEO Robert Bradway described Repatha as one of the company's "growth brands" in a recent conference call with analysts, pointing to recent sales increases.
"I remain optimistic that Repatha will become a significant product for Amgen as it also brings a compelling value proposition to patients," Bradway said.
But the cost debate over PCSK9 treatment continues, as payer roadblocks to uptake remain in place. According to a study published in JAMA Cardiology, less than half of patients newly prescribed PCSK9 inhibitors gained insurer approval. Only a third actually filled their prescription, which may be down to high copays.
In September, the Institute for Clinical and Economic Review, a drug cost watch dog, found the cost of Repatha would need to come down significantly to meet the group's threshold of cost effectiveness (an analysis Amgen disagrees with, for what it's worth).
Since launching Repatha, Amgen has offered a money-back guarantee to payers for any patients who are hospitalized with a heart attack or stroke following treatment — contingent on insurers removing barriers to access.
"We are working extensively with payers at the moment in terms of improving potentially the utilization management criteria and working on trying to reduce the onerous bureaucracy that takes place and frustrates physicians at the moment," said Anthony Hoop, head of commercial operations for Amgen, on a Oct. 25 conference call. "We look forward to being able to pull some of these things through potentially in 2018."