KRYS - Krystal Biotech cleared to file EU marketing application for rare skin disease therapy

• An expert panel of the EU drug regulator has issued a positive opinion on the Pediatric Investigation Plan (PIP) for gene therapy B-VEC, allowing the developer Krystal Biotech, Inc. ( NASDAQ: KRYS ) to file a marketing application targeting a rare skin disorder.
• The companies seeking to file a Marketing Authorization Application for a drug targeted at the pediatric population must submit a PIP to the European Medicines Agency outlining its plans for studies in children.
• The positive opinion adopted by the EMA’s Pediatric Committee allows the company to investigate the drug, also known as beremagene geperpavec, as a treatment for dystrophic epidermolysis bullosa, a rare skin disorder characterized by blisters and open wounds.
• The decision awards the company two years of EU marketing exclusivity for B-VEC in addition to ten-year market exclusivity post regulatory approval.
• Read: B-VEC is “highly approvable,” Seeking Alpha contributor Avisol Capital Partners argues, noting the company’s U.S. marketing application for the treatment filed early this year.

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