Biotech giant Amgen Inc’s new cholesterol drug receives European regulators’ approval

Biotech giant Amgen Inc's new drug for reducing ''bad cholesterol'' has received the approval by European regulators. According to the company, the drug was highly effective in reducing "bad" cholesterol, which was a significant risk factor for heart disease.

The European Commission's approval of the drug Repatha created an important new option for patients who had not been able to cut  cholesterol with existing medications, according to Amgen.

Repatha, an antibody is injected into patients one or two times a month and could reduce low density lipoprotein, or LDL, by 50 per cent or more.

"Repatha addresses the No. 1 killer of humans on the planet," said Sean Harper, Amgen's executive vice president of research and development.

"We are excited to make this new cholesterol-lowering medication available for patients in Europe."

The drug developed by Amgen researchers, is the first in a new class of medications that help the liver to more effectively remove bad cholesterol from the blood and had proved more effective at lowering cholesterol than statins, which had been the standard course of treatment for decades.

Amgen's Repatha formed part of a new class of drugs that block a substance that interferes with the liver's ability to remove bad cholesterol.

The Food and Drug Administration would make a decision on a similar drug from Sanofi and Regeneron Pharmaceuticals on Friday.

The FDA would review Amgen's drug by 27 August.

According to estimates of some analysts, the new class of medicine - including Repatha and drugs planned by other companies - could generate over $10 billion in annual sales.

However, questions remain as to the price of the new drug, which, according to analysts could exceed $10,000 or more per year in the US. Amgen had not disclosed its pricing for Repatha.

The new medications expected to cost $7,000 to $12,000 a year, would however, be far less  expensive than specialty drugs for cystic fibrosis, certain cancers and hepatitis C, but would be far more expensive than many existing statin drugs, which now were available in cheap generic forms.

The new medications are called PCSK9 inhibitors as they blocked a substance that hindered the ability of the liver to remove bad, or LDL, cholesterol from the blood.

According to commentators, if the regulator were to approve the new medications, it probably would do so for only some patients initially - for instance, those who were not able to get their cholesterol levels low enough with statins or those with an inherited disorder that severely elevated LDL levels.