FDA Approves New Cholesterol Drug Praluent

Posted: Jul 25 2015, 8:16am CDT | by , Updated: Jul 25 2015, 8:54am CDT, in News | Latest Science News


Praluent Cholesterol Drug Approved by FDA: 10 Things to Know
Credit: Regeneron.com

10 Things to Know About Praluent before this new cholesterol lowering drug hits the market.

Praluent is a new cholesterol drug which is the first in a new class of biotech medications from Sanofi SA (SASY.PA) and Regeneron Pharmaceuticals Inc (REGN.O) that use a novel approach that lowers artery-clogging cholesterol more than older drugs that have been prescribed for decades.

Approved by FDA and European regulators for millions of patients that face cardiovascular diseases, heart attack, strokes and genetic heart diseases. The FDA decision came hours after the European regulators recommended their approval for the drug to be used, reported CNN.

Praluent and Repatha effectiveness is due to their ability of LDL-lowering drugs that inhibit a protein known as PCSK9. On July 21, European regulators approved Repatha with a broad label covering patients with all familial hypercholesteremia, including the rare, homozygous form, and those with non-hereditary high cholesterol, according to NYTimes.

Competing with Repatha which has already been introduced by Amgen Inc (AMGN.O) and was approved by European Commission. The scenario that is presented in this case is similar to Gilead who introduced a drug called Sovaldi, a rapidly adopted drug for hepatitis C from Gilead Sciences that cost $1,000 a pill. Gilead sold $12.4 billion worth of Sovaldi and a related drug in 2014, the first full year on the market, straining the budgets of insurance companies and Medicaid programs. Gilead was forced to discount its price after a rival drug from AbbVie Inc (ABBV.N) emerged late last year. Same fate can come to Repatha after Praluent will be made available in the market.

Limited FDA approval for Praluent which is only for patients with clinical atherosclerotic cardiovascular disease, including those who have had heart attacks or strokes. It also approved the drug for heterozygous familial hypercholesterolemia (HeFH), the most common hereditary form of high cholesterol. That composes of 8 to 10 million patients, according to Reuters.

Healthcare budgets will skyrocket as the new drug introductory dose will be given every other week by injection in doses of 75 mg or 150 mg. Regeneron said both doses of its drug will be priced wholesale at $1,120 for a 28-day supply. That equates to roughly $14,560 a year which is atleast 50% more than the price of the existent treatment available for controlling cholesterol. 

Healthcare services not happy with the prices of this new course price of Praluent. According to them, cardiovascular diseases are the most common and most prevalent of diseases in the modern day. America's Health Insurance Plans interim chief executive, Dan Durham, said that the $14,560/year would be very exorbitant price which raises concerns as to whether consumers and the health system can sustain the long-term costs despite the medicine’s revolutionary benefits.

Physicians’ reservations are also being taken into account as the permanent result for the medicine’s effectiveness long term has yet to be confirmed. The physicians who can prescribe the medicine are not sure to prescribe it before the results for its clinical trial comes out which are due by 2017.

Statin Use is also predicted to see a decline after the introduction of Praluent, reported Time. Statins have been in use for the control of cholesterol for a long time. The statin use is still being preferred by physicians and healthcare professionals as it literally sells at dime prices compared to what Praluent is suggested to cost.

Praluent use after blood test is being suggested. Healthcare professionals who have reservations over the prices and who or who shouldn’t use the medicine. The answer is simple. The patients not responding to statin will be prescribed to use Praluent. Patients will undergo blood tests to confirm that statin is ineffective.

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