Morning Briefing
Summaries of health policy coverage from major news organizations
Second In New Class Of Cholesterol-Lowering Drugs Approved By FDA
But because PCSK9 drugs are so new, researchers have yet to determine whether their cholesterol-lowering effects actually will translate into fewer heart attacks, strokes and other cardiovascular problems. Over the next couple years, studies should begin to offer clearer answers about how the drugs work over time. While many experts agreed about the promising potential for the new drugs, the price tag for PCSK9 inhibitors already has caused concerns in the health-care world, given the number of patients that eventually could end up using them. (Dennis, 8/27)
The Food and Drug Administration on Thursday approved the second in a new class of cholesterol drugs that promises to dramatically lower cholesterol, although at a very high price. Amgen's Repatha, also known generically as evolocumab, belongs to a new class of injectable cholesterol fighters called PCSK9 inhibitors, which are man-made antibodies. The FDA last month approved the first of these drugs, Praluent, made by Sanofi and Regeneron Pharmaceuticals. Both drugs will cost more than $14,000 a year. (Szabo, 8/28)
Amgen Inc. has won federal approval for the second medicine in a new class of pricey biotech drugs that reduce artery-clogging cholesterol more than older statin drugs that have been used for decades. The drug Repatha could eventually help millions of Americans who face increased risks of heart disease because they cannot control their cholesterol with existing drugs and methods. But concerns about the medication's price tag — $14,100 per year — and long-term benefits will likely limit its use in the near-term. (Perrone, 8/27)
Meanwhile, the FDA also proposes a new convention for labeling biosimilars -
The Food and Drug Administration released its proposal Thursday for naming lower-cost biotech drugs, a critical step in creating a market for the new class of medicines. These quasi-generic biotech drugs have the potential to save the U.S. health care system billions of dollars in costs. But representatives for the generic drug industry warned that the FDA’s proposal could curb those savings by making the drugs more difficult to prescribe. (Perrone, 8/27)
