Dear Epidermolysis Bullosa Community,
We have exciting news to share with you —The US Food and Drug Administration (FDA) has approved B-VEC, for the treatment of dystrophic epidermolysis bullosa (DEB) in patients aged 6 months and older. B-VEC will now be known as VYJUVEK™ (beremagene geperpavec-svdt). VYJUVEK (VYEJOO-VEK), a topical gel, is the FIRST and ONLY treatment that addresses the genetic cause of DEB.
“Krystal was founded in 2016 with the innovative idea of using non-invasive gene therapy to addressthe underlying cause of DEB. Today that idea became a reality,” said Suma Krishnan, President, Research & Development. “I would like to extend a special thank you to the patients living with DEB, their caregivers and families who participated in our clinical development program—and to those who continue to be a part of our ongoing studies. In addition, we extend our sincere gratitude to the patient advocacy groups, researchers and health care providers. Without all of you, this would not have been possible.”
“We are working around the clock on the next phase – getting VYJUVEK to people living with DEB,” said Andy Orth, Chief Commercial Officer. “As part of this effort, we have developed Krystal Connect™, a personalized support program.”
When you contact and enroll in Krystal Connect, you will be connected to a dedicated team. Your team is available to:
- Provide education about VYJUVEK and DEB
- Help you understand your insurance coverage through benefits investigation
- Inform you about financial assistance programs for eligible patients
- Support treatment planning and administration
- Provide information to help you locate a treating doctor in your area
For more information, contact Krystal Connect at 1-844-5-KRYSTAL (1-844-557-9782). You can also visit VYJUVEK.com for updates and the latest information.
Heartfelt thanks to all of you.
Please continue reading for Important Safety Information, and please see Full Prescribing Information.
INDICATION AND USAGE
VYJUVEK is a topical gel used to treat wounds in patients 6 months and older with dystrophic epidermolysis bullosa (DEB).
IMPORTANT SAFETY INFORMATION
VYJUVEK gel must be applied by a healthcare provider.
After treatment, patients and caregivers should be careful not to touch treated wounds and dressings for 24 hours. If accidentally exposed to the VYJUVEK gel, clean the affected area.
Wash hands and wear protective gloves when changing wound dressings. Disinfect bandages from the first dressing change with a virucidal agent, and dispose of the disinfected bandages in a separate sealed plastic bag in household waste. Dispose of the subsequent used dressings in a sealed plastic bag in household waste.
Patients should avoid touching or scratching wound sites or wound dressings.
The most common adverse reactions (>5%) were itching, chills, redness, rash, cough, and runny nose. These are not all the possible side effects with VYJUVEK. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or to the Sponsor at 1-844-557-9782.
Please click here for full Prescribing Information.
Sincerely,
Krystal Biotech
Krystal Connect™, VYJUVEK™, and their associated logos are trademarks owned by Krystal Biotech, Inc.
© Krystal Biotech, Inc. 2023 All rights reserved. VYJ-2300056 v1.0 May 2023
