Applications filed to extend use of Repatha in Europe and USA

Amgen (Nasdaq: AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration and a variation to the marketing authorization to the European Medicines Agency for Repatha(evolocumab), a PCSK9 inhibitor.

The regulatory submissions are based on the 27,564-patient Repatha cardiovascular outcomes study (FOURIER), which showed that maximally reducing low-density lipoprotein cholesterol (LDL-C) levels with Repatha, beyond what is possible with the current best therapy alone, leads to a further reduction in major cardiovascular events, including heart attacks, strokes and coronary revascularizations, said the US biotech giant.

Repatha is in competition with Sanofi and Regeneron's Praluent (alirocumab).Analysts have forecast that both drugs could generate about $3 billion in annual sales by 2022. Repatha was expected to generate about $185 million in sales this year and Praluent as much as $265 million, yet in the first quarter both recorded only about $20 million.