Cholesterol Medicine News Update: FDA Approves New Cholesterol-Lowering Injectable Drug 'Alirocumab'
It has been an exciting week for the health world as the Food and Drug Administration (FDA) approves a one-of-a-kind drug that can lower cholesterol and be administered by injection last Friday.
Fox 2 Now reports that an injectable medication from Regeneron Pharmaceuticals Inc. and Sanofi US has recently been given the green light by FDA. Alirocumab, brand name Praluent, is the first of its kind, known as PCSK9 inhibitors, to offer treatment for high cholesterol in an injectable form.
Dr. Donald A. Smith, an associate professor of medicine and cardiology at the Mount Sinai Hospital in New York, state that Praluent has been endorsed to help individuals with heterozygous familial hypercholesterolemia or HeFh, an inherited disease that triggers the blood cholesterol in the body to shoot up, and those who are victims of stroke or heart attack. Dr. Smith added that with more research on the drug, it can help not only these kinds of patients but also individuals who are in the early stage of cholesterol-related diseases or those who are highly at risk of getting cardiovascular diseases.
However, due to its price of $40 per day, Philly writes that a debate may be looming anytime soon as it may generate concerns from health insurers, doctors and employers. The introduction of breakthrough drugs that are expensive and costly may be disregarded by the public as there are generic statin pills readily available for just a dime.
This is the first time in more than 20 years that a major advancement in cholesterol-related condition treatment has been approved since the discovery of statin drugs, and many analysts already believe that Praulent can generate billions in revenue.
Sanofi executive Dr. Jay Edelberg explained that the $14,600 annual price only reflects how valuable Praluent is for the patients and healthcare system, stating that the use of the drug can still lower what a stroke or heart ailment victim can incur from his medical expenses in over a year.
But the bigger concern among experts is if Praluent can actually live up to its promise of fewer heart problems and deaths. The Centers for Disease Control and Prevention reports that more than 73 millions of American adults are suffering from elevated bad cholesterol, making them twice at risk for heart disease.
The Tampa Tribune writes that Regeron and Sanofi are currently conducting a study that involves 18,000 subjects to prove their claim and will be released to the public by 2017. Many medical experts agree that it will be better to stick to the traditional treatment for now and just limit the use of Praluent to high risk patients.
The FDA is also looking into its approval of a similar drug from Amgen Pharmaceuticals by Aug. 27 while Pfizer's latest entry will be launched in 2018 or at a later date.