Amgen Submits Regulatory Applications For Repatha ® (evolocumab) Cardiovascular Outcomes Data In US And Europe

Applications Based on Data From Repatha Cardiovascular Outcomes Study Showing an Additional Reduction in Heart Attacks, Strokes and Coronary Revascularizations on Top of Optimized Statin Therapy THOUSAND OAKS, Calif., June 5, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a variation to the marketing authorization to the European Medicines Agency (EMA) 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 lipopr...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news