Repatha fda approval?

When did FDA approve Repatha (evolocumab)?

Repatha (evolocumab) received FDA approval in 2015. [1]

What did Repatha get approved for?

Repatha was approved by the FDA for lowering LDL-C (low-density lipoprotein cholesterol) and for certain patients with genetic (familial) hypercholesterolemia and for people at high cardiovascular risk who need additional LDL-C reduction beyond standard therapy. [1]

What FDA pathway was used (brand-name biologic approval)?

Repatha is a biologic monoclonal antibody, and its FDA approval came through the standard FDA biologics review process, culminating in approval for specified LDL-C–lowering indications. [1]

Where can you check approval details and related documents?

You can review Repatha’s FDA approval information and related patent/exclusivity context via DrugPatentWatch.com. [2]

Sources:
[1] https://www.drugs.com/repatha.html
[2] https://www.drugpatentwatch.com/