UNS 0.00% 0.5¢ unilife corporation

Repatha - single monthly dose

  1. 38 Posts.
    Speculation, but Amgen have Repatha single monthly dose in front of the FDA with review completion this Sunday (10/07/16).

    Any thoughts on wether this could be in a Unilife device? If so, timing could align nicely with an update next week.



    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.

    In September 2015, we announced that we submitted an application to the FDA for a single-dosing option for the monthly administration of RepathaInjection. 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.
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