Sold as Vimizim. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Elosulfase Alfa (sold as Vimizim), first approved Feb 14, 2014, with 0 new uses approved and 0 published complete response letters.
| Vimizim | Part D | $20.0M | +29% | 20 |
| Vimizim | Part B | $888K | -65% | 0 |
| Study | Phase | Status | Posted |
|---|---|---|---|
| PEARL (PrEnAtal Enzyme Replacement Therapy for Lysosomal Storage Disorders)MPS I, MPS II · University of California, San Francisco | Phase 1 | Recruiting | Aug 31, 2020 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Feb 14, 2014 | VimizimBLA 125460 · New molecular entity | Biomarin Pharm | 2 | 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
