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Sept 11 (Reuters) - Amgen Inc said on Friday it had asked the U.S. Food and Drug Administration to approve a monthly single-dosing option for its recently approved cholesterol drug, Repatha.
The FDA approved Repatha - one of two expensive treatments in a new class of injectable "bad cholesterol"-lowering drugs called PCSK9 inhibitors - in late August.
A similar drug from Regeneron Pharmaceuticals Inc and Sanofi SA, called Praluent, was approved in July.
Repatha is approved for patients with hereditary forms of high cholesterol - heterozygous familial hypercholesterolemia (HeFH) and a rarer homozygous (HoFH) form of the condition, in addition to those with cardiovascular disease.
It is given as a 140 mg injection every other week or as a monthly injection of 420 mg, which is recommended for HoFH patients, the company said.
At the time of approval, Amgen had said it planned to make the monthly dosing option available next year.
Praluent, which is given every other week by injection in doses of 75 mg or 150 mg.
Praluent has a U.S. price of $14,600 for a year of treatment, while Repatha costs about $14,100. Amgen's drug is being launched in Europe at around half the U.S. price.
In Europe, demand is expected to be limited by budget-conscious governments, many of which have set up healthcare-cost agencies to assess new drugs. Companies often set prices lower to ensure their products are recommended by these agencies.
In the United States, CVS Health Corp and other pharmacy benefit managers are unhappy about the cost of the PCSK9s compared to older cholesterol fighters such as statins, which are available as generics for less than $50 a month.
Amgen, Regeneron and Sanofi have been accused of setting prices that could wreak havoc on the U.S. healthcare system and limit patient use.
But the companies argue that the drugs are more expensive to make and will reduce overall hospital costs because they could prevent heart attacks.
Depending on how they are used, the Institute for Clinical and Economic Review (ICER) estimates that between 3.5 million and 15 million Americans could be eligible for treatment.
(Reporting by Natalie Grover in Bengaluru; Editing by Ted Kerr)