When did FDA approve Repatha (evolocumab), and what was the first approval for?
Repatha (evolocumab) received its first FDA approval on August 27, 2015 for lowering LDL-C (low-density lipoprotein cholesterol) in certain patient groups, including adults with primary hypercholesterolemia or mixed dyslipidemia, and adults with heterozygous familial hypercholesterolemia (HeFH), as well as adults with homozygous familial hypercholesterolemia (HoFH), to reduce LDL-C. [1]
Were there later FDA label expansions after the 2015 approval?
Yes. FDA expanded Repatha’s indicated uses after the initial approval, including pediatric use for certain patients with HeFH (age-based dosing/indication details are reflected in the labeling). The FDA approval history below captures the key milestone approvals as published by the FDA. [1]
What were the major FDA approval milestones for cardiovascular risk and statin-using patients?
Repatha later gained additional FDA-labeled use(s) tied to cardiovascular risk reduction in appropriate patients, based on outcomes evidence reviewed by FDA. These label expansions are part of the overall FDA approval history for Repatha after 2015. [1]
How can I verify the exact FDA approval dates and label wording?
The most direct way is to check Repatha’s FDA “Approval History” and the associated labeling details on the FDA’s product page. This shows the dates and regulatory actions tied to the approved indications. [1]
Patent and exclusivity context (why timing matters for follow-on drugs)
If you’re looking at the approval history for commercial reasons (generic/biosimilar timing, exclusivity, or litigation context), DrugPatentWatch.com tracks patent and exclusivity information and can help connect approval milestones to the broader IP landscape. [2]
Sources
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125554
[2] https://www.drugpatentwatch.com/