Alirocumab, the newly developed drug by Sanofi and Regeneron Pharmaceuticals Inc., hit Phase-III, testing targets that have used the drug on a monthly basis. The results were positive, as the drug proved effective in the reducing of cholesterol levels in patients with hypercholesterolemia.
PCSK9 is a protein produced by the human body that doesn’t allow LDL cholesterol discharge from the liver into the rest of the body. Alirocumab, when injected, works by blocking the PCSK9 protein. Usually, drugs that deter this protein are prescribed to patients for whom earlier treatments have been ineffective or who’s bodies reject the administration of other substances. When cholesterol levels do not plunge even after the intake of statins like Lipitor, which is produced by Pfizer Inc., heavier substances are prescribed.
The cholesterol-lowering drug from Sanofi and Regeneron Pharmaceuticals has been through two Phase-III trials, namely Odyssey Choice I and Odyssey Choice II, determining its efficiency.
In Odyssey Choice I over 800 hypercholesterolemia patients, both with moderate and high cardiovascular risk, participated. The study consisted in administering some of the patients with 300 mg dose of alirocumab and some with a placebo. More than a third also received statin therapy.
Odyssey Choice II used the help of 233 hypercholesterolemia patients characterized with high cardiovascular risk and who could not tolerate statins. No statin therapy was used, but patients were separated into two cathegories: one that received 150 mg of the cholesterol-reducing drug administered monthly, and one that received a placebo.
Although the drug tested very well in both trials, the researchers announced that the most wide-spread side effects of the substance were headache, upper respiratory tract infection, fatigue and nausea. Also, earlier result showed that the drug could pose the risk of heart related conditions to patients.
But overall, the PCSK9 inhibitor was more effective than any other cholesterol-lowering drug available. The trials have demonstrated that the number of high cardiovascular risk patients whose cholesterol levels reduced by alirocumab was ten times bigger than those who were treated with Zetia – Merick & Co. drug.
More and more pharmaceutical companies are focused on developing PCSK9 inhibitors, and they compete to get their own brand of drugs on the market. Billions of dollars are up for grabs if drugs like those produced by Sanofi and Regeneron, Amger, Ing., and Pfitzer can lower heart attacks and deaths related to statins.
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