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IQWiG: Repatha has "no hint" of added benefit

December 24, 2015 1:15 AM UTC

Germany's Institute for Quality and Efficiency in Health Care (IQWiG) said in a dossier assessment that Amgen Inc. (NASDAQ:AMGN) did not provide suitable data supporting the use of Repatha evolocumab to treat hypercholesterolemia, mixed dyslipidemia or homozygous familial hypercholesterolemia (HoFH), and concluded Repatha had "no hint of an added benefit over the appropriate comparator therapy" based on available data.

The agency said studies with a minimum duration of one year would be required to assess Repatha's risk-benefit profile since the PCSK9 inhibitor is used in long-term treatment. IQWiG said Amgen included data from 12-week trials in the dossier. ...