elapegademase-lvlr
Trade name: revcovi
Approved
Oct 5, 2018
Elapegademase, sold under the brand name Revcovi, is a medication for the treatment of the rare disease adenosine deaminase deficiency-SCID in children and adults. — Wikipedia
Clinical trial activity
1 trials · 1 clinical orgs · 2 marketing orgs
Earliest trial started Dec 1, 2013 (NCT01420627)
Timeline
2010s
- Jan 1, 2013
Leadiant Biosciences, Inc. — Earliest Phase 3 Sponsor(trial)
- Mar 19, 2015
Orphan Drug Designation
- Oct 5, 2018
Leadiant Biosciences, Inc. — Earliest FDA Approval
- Oct 5, 2018
Leadiant Biosciences, Inc. — Marketing Organization
- Oct 5, 2018
Leadiant Biosciences, Inc. — NDA Organization
- Oct 5, 2018
Chiesi — NDA Secondary Org
- Oct 5, 2018
Chiesi — Marketing Organization
Indications
Mechanism of action
- Adenosine deaminaseACTIVATOR
ADA activator
- AdenosineHYDROLYTIC ENZYME
Adenosine hydrolytic enzyme
Complements a deficiency of adenosine deaminase.
- 2'-deoxyadenosineHYDROLYTIC ENZYME
2'-deoxyadenosine hydrolytic enzyme
Complements a deficiency of adenosine deaminase.
Approval history
- approvedPriority reviewFast trackOct 5, 2018
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaElapegademase ↗
- NCATS9R3D3Y0UHS ↗
- ChEMBLCHEMBL3990026 ↗
Also known as
- elapegademase-lvlr
- ezn-2279
- ezn-2279
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT01420627 | Phase 3 | Dec 1, 2013 | Leadiant Biosciences, Inc. |
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Leadiant Biosciences, Inc. | For profit | 1 | 1 | 1 | 2013 |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Chiesi | For profit | NDA2 | Oct 5, 2018 |
| Chiesi | For profit | MKTG | Oct 5, 2018 |
| Leadiant Biosciences, Inc. | For profit | MKTG | Oct 5, 2018 |
| Leadiant Biosciences, Inc. | For profit | NDA | Oct 5, 2018 |