August 28, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Thousand Oaks, Calif.-based Amgen announced yesterday that the U.S. Food and Drug Administration (FDA) approved Repatha (evolocumab) Injection, a new drug for cholesterol treatment.
Amgen’s Repatha was in a second-place finish to Regeneron Pharmaceuticals, Inc. and Sanofi ’s approval of Praluent (alirocumab) Injection for cholesterol treatment. Praluent was approved by the FDA on July 24. Both Repatha and Praluent are a new class of drugs called proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors.
PCSK9 inhibitors work by blocking PCSK9, which affects the liver’s ability to remove cholesterol from the blood. Studies have found that using PCSK9 inhibitors with statins cuts LDL cholesterol by 40 to 60 percent, compared to statins, which reduce cholesterol levels by approximately 25 to 35 percent.
Repatha has been chief medical officer for use in two groups of patients who can’t control their cholesterol with existing drugs and treatments due to inherited conditions or who have persistently high LDL levels with a history of heart attack, stroke and other cardiovascular issues. Repatha will be priced at about $14,100 per year. Praluent has a price tag of $14,600 per year.
“The back-to-back approvals for Praluent and Repatha should allow natural market competition to influence the immediate cost for the PCSK9 inhibitors,” said Steve Miller, chief medical officer at Express Scripts Holding Co. in an interview with Reuters. Express Scripts Inc. is a pharmacy benefit manager. “And we plan to leverage this competition to achieve the greatest possible discounts for our clients and patients.”
“Amgen is sensitive to the concerns of payers around cost, budget predictability and paying for value,” said Anthony Hooper, executive vice president of Global Commercial Operations at Amgen in a statement. “We are confident in the ability of Repatha to demonstrate real-world effectiveness and value based on intensive LDL cholesterol reductions, and we will be working with payers and other purchasers to provide innovative pricing programs linking the net price of Repatha to the expected LDL cholesterol reductions and anticipated appropriate patient utilization. By partnering with payers to implement these programs, we can help ensure that all appropriate patients who could benefit from Repatha will have access to this important new therapy.”
The good news for Amgen may also be good news for workers on the East Coast. The company employs 850 people in a manufacturing facility in West Greenwich, R.I. Repatha’s active ingredient is made at the plant. In addition, Amgen is building a research and development site in Cambridge and expects to have 300 people working there by the beginning of 2016, as well as a facility in Woburn that employs 70 people.
The company has been making job cuts in San Francisco, Colorado and Washington, but is hiring at its Cambridge facility. If the drug takes off as expected, and eventually gets broader approval, jobs could follow as product increases.
Analysts project Repatha could hits sales of $60 million this year alone and hit top sales of approximately $3.5 billion by 2022.
