Outcomes Claim May Help Amgen Make Case For PCSK9 Inhibitor Repatha
Labeling for reduction of cardiovascular risk may help a bit with payers, but the "twin problem" of pricing and lack of patient adherence is likely to continue to present hurdles for reimbursement.
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Although only interim data from six treated patients, Capricor’s Phase II DMD study shows improvements in upper limb performance, grip strength and respiration. Cardiac performance shows positive trend, but not yet statistical significance.
ODYSSEY Outcomes data added to US label for Praluent; update includes claim for reduced cardiovascular incident risk and trial data indicating an all-cause mortality benefit.