Belgium-based biopharma UCB (EBR: UCB) announced that it has received marketing approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for two new administration routes for its Rystiggo (rozanolixizumab). This approval allows patients with generalized Myasthenia Gravis (gMG) to self-administer Rystiggo at home using either a manual push or syringe pump method, following training from a healthcare professional.
Rystiggo’s Unique Position
Rystiggo stands as the world’s first and only neonatal Fc receptor (FcRn) antagonist approved for both AChR-positive and MuSK-positive gMG. This innovation marks a significant advancement in the treatment landscape for patients living with this rare condition.
UCB Japan’s Home Delivery Service
In line with the approval, UCB Japan will launch a home delivery service for Rystiggo. This service will include portable syringe pumps and is part of the ONWARD program. ONWARD is a global patient support initiative by UCB designed to assist individuals living with rare diseases like gMG. The program offers features such as symptom tracking, support from dedicated Care Coordinators for each patient, and access to 24/7 online tools.-Fineline Info & Tech
