Amgen wins approval for second biotech cholesterol drug
Amgen Inc has won federal approval for the second medicine in a new class of pricey biotech drugs that reduce arteryclogging 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. The Food and Drug Administration approved the drug Thursday for two groups of patients who face the highest risk of heart disease: patients with extremely high levels of LDL, or bad cholesterol, due to inherited conditions , patients with persistently high LDL levels and a history of heart attack, stroke and other cardiovascular problems.
The drug is designed to be self-injected on a monthly or bimonthly dosing schedule. Thousand Oaks, California-based Amgen priced the drug slightly below a similar drug Praluent, which costs $14,600 per year. Sanofi and partner Regeneron Pharmaceuticals Inc. won FDA approval for that drug last month. Analysts estimate between 8 million to 10 million patients are covered under the FDAapproved labeling for the drugs. But some experts worry the drugs could eventually be expanded for a much wider group of patients, driving up costs as the health care system absorbs a growing wave of retiring baby boomers.
With two competing products now on the market, employers and the companies that manage their medication costs will try to negotiate discounts. Express Scripts, the largest pharmacy benefit manager, said in a statement it plans to “leverage this competition to achieve the best possible price for the patients and payers we represent.” Neither Repatha nor Praluent are currently covered under Express Scripts’ formulary, though the company plans to review them at a meeting next month.
The biologically-engineered drugs are considered the first major advance in managing cholesterol since the introduction of statin drugs more than 20 years ago, and analysts expect them to generate billions in sales. But the prospect of introducing highly-expensive, injectable drugs for one of the most common medical conditions is drawing concerns. Especially since generic statin pills are now available for as little as a dime a day.
More than 73 million US adults, or nearly one-third, have high LDL cholesterol, according to the Centers for Disease Control and Prevention. Those patients have twice the risk of heart disease, the leading cause of death worldwide.
The new drugs lower low-density lipoprotein, or LDL, cholesterol more powerfully and in a different way than statins. They block a substance called PCSK9, which interferes with the liver’s ability to remove cholesterol from the blood. Adding the new drugs to older statins reduces LDL cholesterol by about 40 percent to 60 percent. Statins alone generally lower levels of the wax-like substance by about 25 to 35 percent. —AP