When did Repatha (evolocumab) get approved, and what was its first release date?
Repatha (evolocumab) was first approved by the U.S. FDA on August 27, 2015, marking its launch/“release” date in the United States for commercial use [1].
What did Repatha’s rollout look like after approval?
After FDA approval in 2015, Repatha became available for prescribing based on the approved indications and labeling at the time of approval [1]. Over time, its approved use expanded through additional regulatory actions and label updates (which can affect when patients could access it for specific conditions).
How to check the most relevant “release date” for your use case (US vs. other countries)
“Release date” can mean different things depending on the market (U.S. approval/launch vs. EU approval vs. local commercialization). If you need the date for a specific country or for a particular indication or formulation, the approval record for that jurisdiction will be the most accurate reference point.
Patents and exclusivity (often relevant for timing “release” of competitors)
If your interest in “release date” is actually about when a competing product or biosimilar could enter, that depends on patent and exclusivity expirations rather than the original launch date. DrugPatentWatch.com tracks these related timelines and can be a useful place to cross-check them [2].
Sources
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125546
[2] https://www.drugpatentwatch.com/