Amgen Gets Nod for New Cholesterol Drug

Amgen has won US Food and Drug Administration (FDA) approval for Repatha, the second medicine in a new class of biologics recently greenlighted by the agency and claimed to reduce cholesterol more effectively than older statin drugs.

Prescribed for self-injection on a monthly or bi-monthly dosing schedule, the new drug is designed to meet the needs of patients who cannot control their cholesterol with existing drugs and treatments, specifically those with extremely high levels of low-density lipoprotein, LDL.

According to the US Centers for Disease Control and Prevention (CDC), more than 73 million US adults have high levels of LDL.

The new drugs are claimed to lower LDL more powerfully and in a different way than statins, blocking a substance called PCSK9, which interferes with the liver's ability to remove cholesterol from the blood.

Adding the PCSK9 blockers to older statins has been seen to reduce LDL cholesterol by about 40-60%, compared with 25-35% for statins alone.

The California drugmaker has priced its new product at $14,100 per year, slightly below the $14,600 per year cost of Praluent, which is manufactured by Sanofi and Regeneron Pharmaceuticals and won FDA approval in July. Pfizer is also working on a PCSK9 blocker, which is currently in clinical trials.

The biologically-engineered drugs considered to be the first major advance in managing cholesterol since the introduction of statin drugs more than 20 years ago are expected to generate billions of dollars in sales.

An estimated 8-10 million patients potentially will be covered under the FDA-approved labeling for Repatha and Praulent, but drug market analysts say the high cost of the medication under expanded coverage could drive up costs to health insurers.

Analysts expect Repatha to reach peak sales of about $3.5 billion by 2022, with the entire PCSK9 class of drugs reaching global sales of $10 billion by 2019.