29 August 2017 - Triple designation of orphan drug, fast track status, combined with rare paediatric designation, underscores significant unmet need for therapy.
Prometic Life Sciences today announced that the U.S FDA has granted a rare paediatric disease designation to Prometic’s Ryplazim, a plasminogen replacement therapy for the treatment of patients with congenital plasminogen deficiency.
In addition to the rare paediatric disease designation, Ryplazimä has already been granted orphan drug and fast track designation by the FDA.