Posted by Michael Wonder on 29 Oct 2017
Atara Biotherapeutics receives rare paediatric disease designation from FDA for ATA230 for treatment of congenital cytomegalovirus infection
26 October 2017 - Atara Biotherapeutics today announced that ATA230 was granted rare paediatric disease designation for the treatment of congenital cytomegalovirus infection by the U.S. FDA.
ATA230, an allogeneic T-cell immunotherapy targeting antigens expressed by cytomegalovirus (CMV) has been investigated in one Phase 1 and two Phase 2 clinical studies in immunocompromised patients with CMV viremia or disease who are refractory or resistant to antiviral drug treatment in the post-transplant setting.
The FDA grants rare paediatric disease designation to drugs or biologics intended to treat serious or life-threatening rare diseases that primarily affect individuals aged from birth to 18 years and fewer than 200,000 persons in the U.S. Under this designation, should ATA230 be approved, Atara may be eligible to receive a rare paediatric disease priority review voucher for a biologics license or new drug application for a different product.
