By Jonathan D. Rockoff 

The Food and Drug Administration approved Amgen Inc.'s cholesterol-lowering drug on Thursday, teeing up a rivalry with a similar treatment that was approved just weeks earlier.

The Amgen therapy, Repatha, belongs to a powerful new drug class that promises help for patients who have struggled to control their cholesterol using older statin medicines. In July, the FDA approved the first drug of this new class, Praluent, from Sanofi SA and Regeneron Pharmaceuticals Inc.

Doctors and patients have been looking forward to these new cholesterol-lowering agents, which are injections either monthly or every two weeks. Some 11 million people in the U.S. can't lower their so-called bad cholesterol, LDLs, to healthy levels using statin pills like Lipitor and Crestor, according to Amgen.

"Many patients who are in a state where they cannot get to an acceptable LDL level will benefit," Amgen's research and development chief Sean Harper said in an interview.

Yet health insurers and drug-benefit managers have expressed concerns about the new drugs' cost. Amgen said it is pricing Repatha at $14,100 a year, while Praluent comes in at $14,600. Analysts say the new drug class could eventually reach yearly sales of $10 billion world-wide.

As it did with Praluent, the FDA approved Repatha to be taken with statin drugs, for patients with a hereditary condition called familial hypercholesterolemia or with coronary artery disease that requires additional lowering of cholesterol.

The rivalry between the new agents gives the insurers and drug-benefit managers a chance to negotiate discounts. These payers, like Express Scripts Holding Co., have held off on finalizing decisions about coverage of Praluent because they expected Repatha to be approved soon after.

"We plan to leverage this competition to achieve the best possible price for the patients and payers we represent," an Express Scripts spokesman said.

Such competition, so early in the life of a new drug class, used to be unusual. Drug companies that were first to bring a new drug to market could gain a sizable advantage, said Pratap Khedkar, who leads the pharmaceutical practice at sales and marketing firm ZS Associates.

Yet more recently, rival skin-cancer immunotherapies Keytruda and Opdivo as well as hepatitis C drugs Harvoni and Viekira Pak were approved within a few months of each other. Esbriet and Ofev, competing treatments for a lung-scarring condition, were cleared on the same day last October.

"The order of entry advantage, which used to be significant, is less than it used to be and will probably diminish" further, Mr. Khedkar said.

He suspects the time gap between product approvals is closing because companies are pursuing the same drug targets, often identified by private researchers exploring the molecular roots of disease and then publishing their work for any company to use.

Both Repatha and Praluent work by targeting a protein, called PCSK9, that interferes with the liver's ability to clear cholesterol.

Dr. Harper said the focus on the pricing of the drugs overlooks their potential value preventing life-threatening heart attacks and strokes and avoiding the resulting treatment costs. Studies are under way to establish whether each of the drugs reduce the risk of such events, the goal of cutting cholesterol to desired levels.

More competition could emerge over the next few years from companies like Pfizer Inc. that are developing their own versions of a PCSK9 agent. In addition, companies including Eli Lilly & Co. have been working on a separate new class of cholesterol-fighting agents known as CETP inhibitors.

For Amgen, Repatha sales could help offset competition that is looming for some of its aging biotech drugs. Last month, a U.S. appeals court ruled that Novartis AG could begin sales on Sept. 2 of Zarxio, a lower-priced version of Amgen's Neupogen cancer supportive-care therapy.

Also on Thursday, Amgen said it has asked the court to block Zarxio sales from starting while the judges consider rehearing the case. A spokesman for Novartis said it is aware of the legal request and is looking forward "to launching Zarxio in the U.S. after Sept. 2."

Write to Jonathan D. Rockoff at Jonathan.Rockoff@wsj.com

 

Subscribe to WSJ: http://online.wsj.com?mod=djnwires

(END) Dow Jones Newswires

August 27, 2015 19:45 ET (23:45 GMT)

Copyright (c) 2015 Dow Jones & Company, Inc.
Amgen (NASDAQ:AMGN)
Historical Stock Chart
From Feb 2024 to Mar 2024 Click Here for more Amgen Charts.
Amgen (NASDAQ:AMGN)
Historical Stock Chart
From Mar 2023 to Mar 2024 Click Here for more Amgen Charts.