SUCCESS STORIES: ORPHAN DRUG DESIGNATION GRANTED BY FDA

April 2012

IDIFARMA’s Regulatory Affairs team contributed to the Orphan Drug designation recently granted by the FDA to THR-B7 for treatment of Purpura Fulminans promoted by our client THROMBOLOGIC.

We congratulate THROMBOLOGIC on this success

Purpura fulminans is a rapidly progressive thrombotic disorder affecting neonates and children in which there is haemorrhagic infarction of skin and disseminated intravascular coagulation. It may also herald multi-organ failure or severe large vessel venous thrombosis and therefore causes high initial mortality and long-term morbidity in survivors. Purpura fulminans usually occurs in children, but this syndrome has also been noted in adults.