FDA grants Breakthrough Therapy Scioderm's SD-101 for epidermolysis bullosa
Scioderm’s investigational product SD-101 has received Breakthrough Therapy designation from the FDA for the treatment of inherited epidermolysis bullosa (EB).
SD-101 is being evaluated for the treatment of skin blistering and erosions associated EB, 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., Ppresident and CEO of Scioderm. "Given the recent important milestones for Scioderm, including the Series A $16 million 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."
The FDA Breakthrough Therapy designation for SD-101 in EB patents was based on clinical data from a previously conducted open-label phase II study with topical administration of SD-101 in children with either simplex, recessive dystrophic EB (RDEB) or junctional EB. SD-101 has the potential to facilitate the healing of skin lesions and erosions in this serious and potentially life-threatening disease which has a poor prognosis.