27 August 2015 - The U.S. Food and Drug Administration on Thursday approved Amgen Inc's Repatha drug for patients with hereditary forms of high cholesterol and those with cardiovascular disease.

Last month the FDA approved a similar drug from Regeneron Pharmaceuticals Inc and Sanofi SA. The drugs belong to a potent new class of injectable LDL-lowering drugs known as PCSK9 inhibitors.

Repatha was approved to treat patients with heterozygous familial hypercholesterolemia (HeFH) and patients with the rarer homozygous (HoFH) form of the disease. It was also approved for patients with cardiovascular disease including heart attack or stroke, who require additional cholesterol lowering.

Praluent is given every other week by injection in doses of 75 mg or 150 mg. Both doses of the drug will be priced wholesale at $1,120 for a 28-day supply, or roughly $14,560 a year.  After rebates, analysts expect the drug to cost about $12,400 a year.

Repatha is given as a 140 mg injection every other week or as a monthly injection of 420 mg. Amgen said the wholesale cost of the drug will be $14,100 a year for the every other week injection. The product will be available next week.

Amgen said it plans to make the monthly dosing option available next year.

For more details; go to: http://www.reuters.com/article/2015/08/27/amgen-repatha-fda-idUSL1N1122KX20150827