Drug Profile
Prademagene zamikeracel - Abeona Therapeutics
Alternative Names: EB-101; Epidermolysis bullosa gene therapy - Abeona Therapeutics; Gene-corrected skin grafts - Abeona Therapeutics; LEAES; LZRSE COL7A1; LZRSE-Col7A1 Engineered Autologous Epidermal Sheets; Pz-celLatest Information Update: 24 Apr 2024
Price :
$50
*
At a glance
- Originator Abeona Therapeutics
- Class Cell therapies; Gene therapies; Skin disorder therapies
- Mechanism of Action Collagen type VII replacements; Gene transference
-
Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
- Available For Licensing Yes
Highest Development Phases
- Preregistration Epidermolysis bullosa dystrophica
Most Recent Events
- 23 Apr 2024 Abeona Therapeutics receives complete response letter from the FDA for prademagene zamikeracel in Epidermolysis bullosa dystrophica
- 25 Mar 2024 The US FDA completes a pre-license inspection of Cleveland, Ohio manufacturing facility and issues a new Form 483
-
27 Nov 2023
The US FDA assigns PDUFA action date of 25/05/2024 for Prademagene zamikeracel for Epidermolysis bullosa