ZEVASKYN™

ZEVASKYN Logo

ZEVASKYN® (prademagene zamikeracel), developed by Abeona Therapeutics, is the first and only autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB). 

Made from your own skin cells that have been gene-modified to express functional collagen 7, ZEVASKYN sheets help address the genetic cause of RDEB in treated wounds. Up to 12 credit card–sized sheets (41.25 cm2 each) are applied to cover multiple individual wounds or joined together to cover larger areas. 

Overview

EB Type

 Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Approved Age

 Approved for use in both adult and pediatric patients with RDEB.

Product Description

ZEVASKYN is made from your own skin cells that are gene modified to express functional collagen 7. It is applied surgically at a Qualified Treatment Center in an operating room under general or other appropriate anesthesia. 

  • Each ZEVASKYN sheet is about the size of a credit card (5.5 cm x 7.5 cm). 
  • Up to 12 sheets may be made from your skin sample and used in a single surgery. 
  • The number of sheets used depends on the number and the size of your wounds. They can be applied to cover multiple individual wounds or joined together to cover larger areas.  
  • All selected sheets must be applied in a single surgical session. 
  • The treated area must be left undisturbed for 5-10 days.  

Product Manufacturing
  • Two 8 mm samples of your own skin (the size of 2 small peas) are collected using a method called a punch biopsy at a Qualified Treatment Center.  
  • After biopsy, you return home while the cells are sent to Abeona to be genetically modified and grown into sheets. 
  • In ~25 days you travel back to the Qualified Treatment Center where ZEVASKYN sheets are applied in a single surgery under general or other appropriate anesthesia. 

 

Select Safety Information

 Serious allergic reactions, including anaphylaxis, may occur. There is a potential risk of developing cancer; lifelong monitoring is recommended. ZEVASKYN is made using human and animal materials, and there is a small risk of infection transmission. The most common side effects are pain from the procedure and itching. Call your doctor for medical advice about side effects. 

Prescribing Information

 Full Prescribing Information

Getting Started

ZEVASKYN is available through ZEVASKYN Qualified Treatment Centers (QTCs), which are well-recognized EB treatment centers situated across the U.S. 

Abeona Assist™ is Abeona’s comprehensive support program designed to provide personalized assistance every step of the way. The program helps patients understand how to access ZEVASKYN, reviews insurance coverage and financial assistance options, and offers travel and logistical support for eligible individuals.  

For more information, to access ZEVASKYN support and resources, or to locate a ZEVASKYN Qualified Treatment Center (QTC), please call Abeona Assist or visit: 

855-ABEONA-1 (855-223-6621)

Access ZEVASKYN Support and Resources

Abeona Assist Logo

 

 

 

 

 

Back to Approved Treatments Page