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Investing.com -- Krystal Biotech Inc (NASDAQ:KRYS) stock rose 7.3% Monday following FDA approval of a label update for its VYJUVEK treatment that significantly expands the eligible patient population and application flexibility.
The updated label now allows dystrophic epidermolysis bullosa (DEB) patients from birth to receive the treatment, compared to the previous age restrictions. Additionally, patients and caregivers can now apply the medication themselves at home and have greater flexibility in managing wound dressings, which can be removed during the next dressing change rather than waiting 24 hours.
"We believe 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," said Krish S. Krishnan, Chairman and CEO of Krystal Biotech .
The label update was supported by real-world data collected since VYJUVEK’s U.S. launch, along with results from an open label extension study published earlier this year. These findings reinforced the treatment’s long-term safety and efficacy across patients of all ages, including when applied by patients or caregivers.
Brett Kopelan, Executive Director of debra of America, called the label update "another significant and impactful step forward for all those living with DEB," noting that it allows for "increased convenience without sacrificing safety."
VYJUVEK is positioned as a treatment for DEB wounds regardless of wound size and severity, with the company suggesting these changes will improve patient compliance by making it easier to integrate the treatment into daily routines.
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