DecoDerma granted rare pediatric disease (RPD) designation for rare disease epidermolysis bullosa by the FDA
The benefit of obtaining RPD designation is that the FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. Under this program, a sponsor who receives an approval for a drug or biologic for a "rare pediatric disease" may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.
The DecoDerma team is led by Professor & Chief Surgeon Tero Järvinen (M.D., Ph.D.), Tampere University (Finland). “DecoDerma is excited to receive RPD designation from the FDA. The RPD designation could facilitate our molecule´s drug development towards usage in children in one of the most devastating diseases of mankind, epidermolysis bullosa” states professor Järvinen.
The DecoDerma-team is developing a potentially life-saving drug for rare pediatric skin disease, epidermolysis bullosa. Their molecule is a recombinant, multi-functional fusion protein that has both a targeting and tissue penetrating peptide (tCRK peptide) for an efficient delivery of the molecule to normal skin and skin wounds and Decorin (DCN) anti-inflammatory and anti-fibrotic protein as an active therapeutic component. The team has demonstrated the best-in-class position in the lethal, pre-clinical disease model of EB.
The DecoDerma team is focused to create novel systemic treatment for lethal skin disease, EB, but the molecule has other potential disease indications; among them suppression of tumor growth.
DecoDerma has carried out proof-of-concept studies successfully, has received the orphan drug designation (ODD) for their molecule from the EMA in Europe and from the FDA. The company was selected as one of the most promising startup companies in Scandinavia by both the Nordic Innovation Fair (NIF) and the Nordic Life Science days (NLSD) in 2022. Recently, SPARK Stanford and SPARK Global startup incubator programs selected DecoDerma among the best 10 global academic biotech startup companies. DecoDerma is currently raising capital for moving the molecule to clinical trials in EB patients to address the unmet medical need in one of the most devastating diseases in mankind.
More info can be found on our project website DecoDerma. More information about the RPD designation and priority review vouchers can be found (https://en.wikipedia.org/wiki/Priority_review).
