Scioderm announced its investigational product SD-101 has received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with inherited Epidermolysis Bullosa (EB). SD-101 is Scioderm’s investigational therapy that is being evaluated for the treatment of skin blistering and erosions associated with this disease, including facilitation of healing of skin lesions and reduction of the incidence and/or severity of new lesions.
“We are truly honored to have received Breakthrough Therapy designation for SD-101 and are pleased with the FDA’s decision to place our product in a category that may enable expedited development and review for patients with Epidermolysis Bullosa,†said Robert Ryan., Ph.D., President and Chief Executive Officer of Scioderm. “Given the recent important milestones for Scioderm, including the Series A $16M closing along with this designation, we are looking forward to the opportunity to collaborate more closely with the FDA and potentially expedite the availability of an important new treatment option for patients with a disease that has no current effective treatment.â€
