Sanofi, Regeneron experimental drug lowers risk of stroke, heart attack

Stroke and heart disease account for two of the leading causes of death in the world. That may soon change after a drug was proven to lower risks for heart attacks and stroke in a clinical trial.

Called alirocumab, the drug is being developed by Sanofi and Regeneron Pharmaceuticals. Researchers reported Sunday that alirocumab is capable of cutting risks for heart attacks and strokes by up to 50 percent, highlighting potential benefits for millions of patients.

Alirocumab is part of a new class of drugs called PCSK9 or proprotein convertase subtilisin / kexin type 9 inhibitors. It works by mimicking a rare condition in the body wherein low cholesterol levels are a natural occurrence. When a dose of alirocumab is received, the PCSK9 enzyme in the body is blocked, lowering levels of LDL or bad cholesterol in the body. It is necessary to keep PCSK9 in check because when uncontrolled, the enzyme will prevent liver cells from metabolizing bad cholesterol which will lead to higher amounts of fat in the blood.

While results from research on alirocumab are not conclusive, they provide first evidence that inhibiting PCSK9 in the body can significantly reduce risks of heart attacks and stroke in people.

It was announced in July that nine major studies have consistently showed alirocumab reduces levels of bad cholesterol in the body, but details from four trials were only recently revealed at the annual meeting of the European Society of Cardiology held in Barcelona.

Sanofi and Regeneron aren't the only ones banking on PCSK9 inhibitors though. Amgen and Pfizer, Merck & Co., Roche, Alnylam Pharmaceuticals, and Eli Lilly & Co. are also in the market for PCSK9 inhibitors, which analysts estimate could be worth $1.3 billion by the year 2020. To expedite regulatory review in the U.S., Sanofi and Regeneron paid $67.5 million to receive a voucher from BioMarin Pharmaceutical.

In the United States alone, around 12 million people have problems keeping bad cholesterol levels down. Bad cholesterol is bad because it increases risks for heart attacks and strokes by clogging a person's arteries. Sanofi and Regeneron estimate that about 21 million patients in the U.S. and Europe can benefit from alirocumab.

PCSK9 drugs will be first targeted towards people with rare familial conditions that push their cholesterol levels dangerously high, as well as patients who can't tolerate statin, and those whose current medications are struggling to control cholesterol levels in the body.

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