MYOZYME (alglucosidase alfa) · Sanofi
Details
- Status
- Prescription
- First Approved
- 2006-04-28
- Patent Cliff
- 2013
- Revenue
- $124.2M (Q2-2026)
- Routes
- IV (INFUSION)
- Dosage Forms
- INJECTABLE
MYOZYME Approval History
What MYOZYME Treats
1 FDA approvalsOriginally approved for its first indication in 2006 .
- Other (1)
MYOZYME Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Sanofi's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03729362 PROPEL results posted | ATB200-03 | Ph 3 | completed | A Study Comparing ATB200/AT2221 With Alglucosidase Alfa/Placebo in Adult Subjects With Late-onset Pompe Disease |
| NCT04676373 APOLLO-LOPD | ALGMYL09010 U1111-1238-1267, LPS15677 | Ph 4 | completed | Study to Evaluate Efficacy and Safety in Chinese Patients With Late Onset Pompe Disease With Alglucosidase Alfa Treatmen |
| NCT00486889 results posted | AGLU03606 LTS12869, U1111-1163-0368 | Ph 4 | completed | Growth and Development Study of Alglucosidase Alfa |
| NCT01410890 PAPAYA results posted | AGLU07710 2010-022231-11, MSC12790 | Ph 4 | completed | Pharmacokinetics of Alglucosidase Alfa in Patients With Pompe Disease |
| NCT01597596 results posted | AGLU07510 2011-005595-42 | Ph 4 | terminated | A Noninferiority Study of Alglucosidase Alfa Manufactured at the 160 L and 4000 L Scales in Treatment Naïve Patients With Infantile-Onset Pompe Disease |
| NCT01526785 results posted | AGLU09411 EFC12720 | Ph 4 | terminated | A Study to Evaluate the Efficacy and Safety of Alglucosidase Alfa Produced at the 4000 L Scale for Pompe Disease |
| NCT01288027 results posted | AGLU07310 2010-020611-36, MSC12823 | Ph 4 | completed | Exploratory Muscle Biopsy Assessment Study in Patients With Late-Onset Pompe Disease Treated With Alglucosidase Alfa |
| NCT00701129 results posted | AGLU03807 MSC12862 | Ph 4 | completed | An Exploratory Study of the Safety and Efficacy of Prophylactic Immunomodulatory Treatment in Myozyme-naive Cross-Reacting Immunologic Material (CRIM[-]) Patients With Infantile-Onset Pompe Disease |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MYOZYME FDA Label Details
Pro Intelligence Preview
Deep insights for MYOZYME
Revenue Insights
- • Q2-2026: $124.2M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2013
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.