Amgen wins first approval for new class of cholesterol drugs

The European Commission’s approval of the drug Repatha creates an important new option for patients who had not been able to reduce cholesterol with existing medications, said the company, based west of Los Angeles in Thousand Oaks. The injectable Repatha, also known as evolocumab, helps the liver remove “bad” cholesterol from the bloodstream.

Highlighting significant unmet medical need, Amgen noted that more than 60% of high-risk patients in Europe are still unable to adequately lower their LDL-C levels with statins or other medicines, a figure which is thought to be more than 80% in very high risk patients, putting them at a much higher risk from developing cardiovascular disease.

“Repatha addresses the No. 1 killer of humans on the planet”, said Sean Harper, executive vice president of research and development at Amgen.

The drug is part of a new class of LDL-lowering drugs that inhibit a protein known as PCSK9.

The European approval for Repatha will handle individuals along with a preprocessing propensity to large cholesterol and such intolerance of statins or can not understand well enough take pleasure in one, the biotechnology firm said on Tuesday. The USA Food and Drug Administration is expected to decide whether to approve Repatha by August 27. Amgen has not disclosed its pricing for Repatha.

Repatha and its rival drug Praluent are expected to generate global annual sales of more than $2 billion each by 2020, according to Thomson Reuters Cortellis.

Amgen shares closed down 64 cents or a fraction of a percent to $163.70 on the Nasdaq.