FDA Expands Krystal Biotech Vyjuvek's Label Allowing Newborns Access To Gene Therapy For Blistering Skin

Benzinga

Sep 16

The U.S. Food and Drug Administration (FDA) on Monday approved Krystal Biotech, Inc.’s KRYS label update for Vyjuvek (beremagene geperpavec-svdt). The update expands the Vyjuvek eligible patient ...

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The label update is based on real-world data collected since Vyjuvek launch in the U.S., as well as results from the open label extension study conducted in the U.S. and published earlier this year, which collectively reinforce the long-term safety and efficacy of Vyjuvek across patients of all ages, including in cases of patient or caregiver application.Pric","collect":0,"end_time":0,"defaultTopTitle":"benzinga.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4077":"互动媒体与服务","EB":"Eventbrite Inc.","BK4108":"电影和娱乐"},"translate_title":"FDA扩大Krystal Biotech Vyjuvek的标签，允许新生儿获得皮肤起泡的基因治疗","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"EB":1},"content_text":"The U.S. Food and Drug Administration (FDA) on Monday approved Krystal Biotech, Inc.’s KRYS label update for Vyjuvek (beremagene geperpavec-svdt).\nThe update expands the Vyjuvek eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth and provides patients full flexibility with respect to Vyjuvek application and managing wound dressings.\nEpidermolysis bullosa (EB) is a group of rare, inherited genetic conditions that cause the skin and mucous membranes to be fragile, leading to painful blisters and skin erosions from minor friction or trauma.\nAlso Read: Abeona Surges After FDA Clears First Gene Therapy For Severe Genetic Skin Disease\nThe label update also affords patients greater flexibility in managing wound dressings. Wound dressings are now permitted to be removed as part of the next dressing change rather than waiting 24 hours, further integrating Vyjuvek into existing wound care routines.\nThe label update is based on real-world data collected since Vyjuvek launch in the U.S., as well as results from the open label extension study conducted in the U.S. and published earlier this year, which collectively reinforce the long-term safety and efficacy of Vyjuvek across patients of all ages, including in cases of patient or caregiver application.\nWall Street welcomed the broader label. In a research note, William Blair wrote, “Vyjuvek’s appealing at-home dosing, its potential to impact patient behavior and quality of life, and the sizable ROW opportunity could all contribute to a strong revenue tail.”\nAnalyst Sami Corwin reiterated that the company’s current valuation does not reflect the long-term revenue potential of Vyjuvek and catalysts from its clinical pipeline over the next 12 months.\nPrice Action: KRYS stock is trading higher by 6.01% to $152.32 at last check Monday.\nRead Next:\nPhoto via Shutterstock","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}