FDA OKs Breakthrough Cholesterol Drug

A survey of physicians published this morning by Geoffrey Porges, an biotechnology analyst at investment bank Sanford C. Bernstein, found that they would use the drug in 30% to 40% of patients who had already had heart attacks. It also approved the drug for heterozygous familial hypercholesterolemia (HeFH), the most common hereditary form of high cholesterol.

Most people who have muscle problems from statins do not have those elevated muscle enzymes, says Nissen, the Cleveland Clinic cardiologist, who is conducting a clinical trial Amgen and Pfizer, which is also developing a similar cholesterol drug. Especially since generic statin pills are now available for as little as a dime a day. Thus far the feedback we have received has been largely negative, and investors are citing the lack of inclusion of primary prevention as more narrow than expected. Regeneron shares were down 2.5% in afternoon trading before they were halted pending news. They must be self-injected by patients, with Praluent dosed every two weeks. Repatha is designed to be given as a 140 mg injection every other week or a monthly injection of 420 mg.

“Praluent provides another treatment option for patients with [high cholesterol] or with known cardiovascular disease who have not been able to lower their LDL cholesterol enough on statins”, said John Jenkins, MD, director of the Office of New Drugs, Center for Drug Evaluation and Research, in a press release. While up to 3 million people have Hepatitis-C in the U.S., Sovaldi can cure their disease, so the $150 billion maximum price tag for treating them could be spread out over a decade, not absorbed in just one year, the CVS execs wrote.

It might be a big step in the battle against heart disease – and the approval is a triumph for Regeneron Pharmaceuticals, the Tarrytown, N.Y.-based biotechnology company that invented it. Praluent is likely to be more widely used, and to cost more, than Wall Steet analysts expected. Earlier Friday, the European Medicines Agency’s own advisory panel, the CHMP, recommended approval of Praluent for the same groups. On Tuesday, it was approved in Europe for patients with a broad label for both genetic and nongenetic high cholesterol, with statin intolerance specifically mentioned.

The injectible drug, called Praluent, has raised eyebrows because it costs about $14,000 a year per patient, but researchers have called it a breakthrough because of its ability to reduce cholesterol levels. Gilead was forced to discount its price after a rival drug from AbbVie Inc emerged late previous year. The Sanofi-Aventis and Regeneron Pharmaceuticals drug is the first in a new class of injectable, cholesterol-lowering drugs.

Under the terms of its partnership with Sanofi, Regeneron will receive 50 percent of profits from the drug in the United States, and between 25 and 45 percent of profits made elsewhere.