Posted by Michael Wonder on 11 Jun 2020
Rezolute receives rare paediatric disease designation for RZ358, Phase 2b candidate for the treatment of congenital hyperinsulinism, enabling eligibility for priority review voucher
10 June 2020 - Rezolute today announced that the company has received rare paediatric disease designation from the FDA for RZ358, a potential treatment for congenital hyperinsulinism that is currently being evaluated in a global Phase 2b study.
RZ358 is a monoclonal antibody designed specifically to address congenital hyperinsulinism, an ultra-rare genetic endocrine disorder that appears in 1 in 25,000 to 1 in 50,000 live births in many populations.
