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Alirocumab: New Drug to Cut Cholesterol, Prevent Heart Attack
- Updated: August 31, 2014
A new drug developed by Sanofi and Regeneron Pharmaceutical cuts down high cholesterol levels but also risk of heart disease. In a total of nine trials, this drug also shows early indications of being able to prevent heart attack and death.
The combined studies included 2,341 patients who were administered the new drug called Alirocumab. The result after six months was an impressive 62% reduction in levels of bad cholesterol compared to patients who received a placebo. The analysis also showed risk of related hospitalization, heart attack, stroke, and death was reduced by 50% compared to the placebo group.
Currently, Sanofi is trying to beat the competition to the finish line in marketing a new class of drugs called PCSK9 inhibitors. These drugs are designed to mimic a rare genetic condition that causes people to have low cholesterol levels. However, its competitor, Amgen, a California based company has already submitted the product in the United States.
Sanofi, which is located in Paris, sent out a statement that they would be following in Amgen’s footsteps later this year. At that time, they will try to obtain a priority review by the United States Food and Drug Administration (FDA) via voucher. According to head of research and development for Sanofi, Elias Zerhouni, the company does not like being second to Amgen.
With such promising numbers, other pharmaceutical manufacturers are also developing PCSK9 inhibitors to include Pfizer, Alnylam Pharmaceuticals, Merck & Co., Roche Holding AG, and Eli Lilly & Co. After all for patients who cannot take or are not currently helped by a class of cholesterol lowering drugs known as Statins, this new drug offers hope.
Today, there are approximately 21 million people worldwide who are not able to get high cholesterol levels down using Statins. Considering that both heart disease and stroke are top causes of death, having the ability to reduce levels that ultimately lower or prevent major problems associated with the heart is tremendously good news.
The drugs developed by both Sanofi and Magen block the PCSK9 enzyme responsible for high cholesterol. If this enzyme is not controlled, it prevents cells in the liver form processing LDL cholesterol, which in turn increases the amount of fat in the blood.
According to Sanofi and Regeneron in a statement released last month, the main goal of nine trials has been met with Alirocumab. While no additional information was provided by the companies, they did present results from four of the nine studies at the European Society of Cardiology. Initial reduction was great but after receiving treatment for a full year, 57% of the patients who took Alirocumab maintained a healthy level of cholesterol.
Information gathered from the “Odyssey Long-Term Trial” indicates that Alirocumab is the drug that doctors and patients have been waiting for. However, a larger study named “Odyssey Outcomes”, will be used to offer conclusive evidence of the smaller studies. As stated by Zerhouni, this is the first time that a second drug has been developed that seems to indicate a beneficial outcome.