BLA 125117, held by Biomarin. Galsulfase.
As of Nov 13, 2026, BLA 125117 (Naglazyme), held by Biomarin, was first approved by FDA on May 31, 2005, with 7 approved supplements and 0 published complete response letters.
NAGLAZYME is indicated for patients with Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 28, 2011 | Supplement 90Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2011 | Supplement 88Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2011 | Supplement 86Efficacy (new indication or use) · Standard review | Approved | |
| May 31, 2005 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Naglazyme5MG/5ML · injectable; injection | Galsulfase | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 12, 2024 | Supplement 132Labeling · Standard review | Approved | |
| Jul 10, 2024 | Supplement 131Labeling · Standard review | Approved | |
| Dec 17, 2019 | Supplement 129Labeling · Standard review | Approved | |
| Mar 26, 2013 | Supplement 111Labeling · Standard review | Approved | |
| Apr 28, 2011 | Supplement 90Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2011 | Supplement 88Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2011 | Supplement 86Efficacy (new indication or use) · Standard review | Approved | |
| May 31, 2005 | 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
