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Treats acquired thrombotic thrombocytopenic purpura (aTTP). Sold as Cablivi. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Caplacizumab-Yhdp (sold as Cablivi), first approved Feb 6, 2019, with 1 new use approved and 0 published complete response letters.
First approved: Feb 6, 2019
Applications: 1
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $28.9M
First approved in the EU: Aug 30, 2018
First approved in Japan: Sep 26, 2022
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 44 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Cablivi, new ingredientA drug with a new active ingredient indicated for the treatment of acquired thrombotic thrombocytopenic purpura. · Sanofi K.K. · Sep 26, 2022 · Review report
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
