Treats perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). BLA 125513, held by Alexion Pharm. Asfotase Alfa.
As of Nov 13, 2026, BLA 125513 (Strensiq), held by Alexion Pharm, was first approved by FDA on Oct 23, 2015, with 4 approved supplements and 0 published complete response letters.
STRENSIQ is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 12, 2020 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Oct 23, 2015 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Strensiq18MG/0.45ML · solution;injection | Asfotase Alfa | Rx |
| Strensiq28MG/0.7ML · solution;injection | Asfotase Alfa | Rx |
| Strensiq40MG/ML · solution;injection | Asfotase Alfa | Rx |
| Strensiq80MG/0.8ML · solution;injection | Asfotase Alfa | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 10, 2024 | Supplement 33Labeling · Standard review | Approved | |
| Jun 12, 2020 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Jan 26, 2018 | Supplement 3Labeling · Standard review | Approved | |
| Oct 18, 2016 | Supplement 2Labeling · Standard review | Approved | |
| Oct 23, 2015 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
