Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Sold as Takhzyro. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Lanadelumab-Flyo (sold as Takhzyro), first approved Aug 23, 2018, with 1 new use approved and 0 published complete response letters.
First approved: Aug 23, 2018
Applications: 1
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $269M
Orphan exclusivity until: Feb 3, 2030
First approved in the EU: Nov 22, 2018
First approved in Japan: Mar 28, 2022
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Treatment of angioedemaTakeda Pharmaceuticals U.S.A., Inc. · designated Nov 26, 2013 · approved Aug 23, 2018
Treatment of angioedemaTakeda Pharmaceuticals U.S.A., Inc. · designated Nov 26, 2013 · approved Feb 3, 2023 · exclusive to Feb 3, 2030
Approvals in the EU (EMA)
First approved in the EU 3 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals
Takhzyro, new substanceTakeda Pharmaceuticals International AG Ireland Branch · Nov 22, 2018
Approvals in Japan (PMDA)
First approved in Japan 43 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Takhzyro, new ingredientA drug with a new active ingredient indicated for the prophylaxis of acute attacks of hereditary angioedema. · Takeda Pharmaceutical Company Limited · Mar 28, 2022
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
