Krystal Biotech Receives FDA Approval for Expanded VYJUVEK Label, Allowing Treatment of DEB Patients from Birth and Simplifying Application Process

Krystal Biotech has announced FDA approval for an updated VYJUVEK label, expanding the eligible patient population to include DEB patients from birth and allowing patients and caregivers to apply VYJUVEK themselves. The label update also provides flexibility in managing wound dressings. This change is based on real-world data and reinforces VYJUVEK's position as the most flexible and convenient treatment for DEB patients in the US.

Krystal Biotech (NASDAQ: KRYS) has received FDA approval for an updated label for its gene therapy treatment, VYJUVEK®, which expands the eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth and allows patients and caregivers to apply the treatment themselves. The label update also provides greater flexibility in managing wound dressings, further enhancing the convenience and accessibility of the treatment Krystal Biotech Announces FDA Approval of Updated VYJUVEK® Label^[1].

The key changes in the updated label include:
1. Expanded Patient Eligibility: VYJUVEK can now be used on DEB patients from birth, previously restricted to adult and pediatric patients.
2. Self-Application: Patients and caregivers are now authorized to apply VYJUVEK, reducing the need for healthcare professional administration.
3. Flexible Wound Dressing Management: Dressings can be removed during the next dressing change rather than waiting 24 hours, better integrating VYJUVEK into existing care routines.

These modifications are supported by real-world data and results from an open-label extension study, demonstrating VYJUVEK's long-term safety and efficacy across all age groups Krystal Biotech Announces FDA Approval of Updated VYJUVEK® Label^[1].

Krystal Biotech's CEO, Krish S. Krishnan, stated, "These changes further reinforce VYJUVEK’s leadership position as the most flexible, convenient, and disease-modifying medicine to treat DEB patients in the United States. By providing patients and their caregivers the ability to apply VYJUVEK themselves, we have made it easier for patients to integrate VYJUVEK into their daily routines and lifestyle" Krystal Biotech Announces FDA Approval of Updated VYJUVEK® Label^[1].

The endorsement from debra of America, a patient advocacy organization, validates the meaningful impact these changes will have on patient quality of life Krystal Biotech Announces FDA Approval of Updated VYJUVEK® Label^[1].

The label update is expected to positively impact compliance rates, a critical factor for both patient outcomes and consistent revenue generation for Krystal Biotech. This regulatory win strengthens VYJUVEK's position as the standard of care for DEB wound treatment across all severity levels Krystal Biotech Announces FDA Approval of Updated VYJUVEK® Label^[1].