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In August 2015, we announced that the FDA granted approval of Repatha™ Injection as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of low density lipoprotein cholesterol (LDL-C); and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia, who require additional lowering of LDL-C. The effect of Repatha on cardiovascular morbidity and mortality has not been determined.
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In September 2015, we announced that we submitted an application to the FDA for a single-dosing option for the monthly administration of Repatha™ Injection. The FDA has set a July 10, 2016, Prescription Drug User Fee Act (PDUFA) target action date as a goal for the completion of their review of our application.
UNS Price at posting:
7.7¢ Sentiment: Hold Disclosure: Held
