Asfotase Alfa

Treats perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). Sold as Strensiq. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Asfotase Alfa (sold as Strensiq), first approved Oct 23, 2015, with 1 new use approved and 0 published complete response letters.

First approved: Oct 23, 2015
Applications: 1
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $435M
First approved in the EU: Aug 28, 2015
First approved in Japan: Jul 3, 2015

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Strensiq	Part D	$435M	+26%	373

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of hypophosphatasiaAlexion Pharmaceuticals, Inc. · designated Sep 12, 2008 · approved Oct 23, 2015

Approvals in the EU (EMA)

First approved in the EU 2 months before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Strensiq, new substanceAlexion Europe SAS · Aug 28, 2015

Approvals in Japan (PMDA)

First approved in Japan 4 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Strensiq, new ingredientDrugs with a new active ingredient indicated for the treatment of hypophosphatasia. · Alexion Pharma G.K. · Jul 3, 2015 · Review report

Clinical Trials

4 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase AlfaHypophosphatasia · Alexion Pharmaceuticals, Inc.	Phase 3	Active, not recruiting	Oct 12, 2023
Phase 3 Study of ALXN1850 Versus Placebo in Adolescent and Adult Participants With HPP Who Have Not Previously Been Treated With Asfotase AlfaHypophosphatasia · Alexion Pharmaceuticals, Inc.	Phase 3	Active, not recruiting	Oct 12, 2023
Phase 3 Study of ALXN1850 in Treatment-Naïve Pediatric Participants With HPPHypophosphatasia · Alexion Pharmaceuticals, Inc.	Phase 3	Active, not recruiting	Oct 12, 2023
A Prospective Sub-Study of the Global Hypophosphatasia RegistryHypophosphatasia · Alexion Pharmaceuticals, Inc.	—	Recruiting	Feb 10, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Oct 23, 2015	StrensiqBLA 125513 · New molecular entity	Alexion Pharm	4	Marketed

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