Pediatric Committee, new recommendations

The Pediatric Committee (PDCO) of the European Medicine Agency has published some recommendations issued during their meeting in January.  PDCO approved the Pediatric Investigation Plans of 6 medicines: recombinant coagulation factor VIIa for the treatment of congenital coagulation disorders and acquired haemophilia; TH-302 for the treatment of soft tissue sarcoma and Ewing’s sarcoma; eravacycline for the treatment of complicated intra-abdominal infections and urinary tract infections; emtricitabine in combination with other drugs for the treatment of HIV infection; and efinaconazole for the treatment of onychomycosis. PDCO has also expressed a positive opinion on the conformity of a program of trials established by the PIP of normal human immunoglobulin in the treatment of primary immunodeficiency. The activities of PDCO include the assessment of PIPs, that are at the basis of clinical and non clinical quality for the pediatric population. PDCO also checks the performance of the program of trials established by PIPs before new MA applications and type II variations.