Rystiggo (rozanolixizumab) receives approval in Japan for two new administration methods for people living with generalized Myasthenia Gravis (gMG) - UCB

UCB announced that it has received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for at-home self-administration with infusion pump or a new manual push syringe method for Rystiggo (rozanolixizumab). With this approval, people living with generalized Myasthenia Gravis (gMG) can now self-administer Rystiggo at home using either a manual push or syringe pump method, following training from a healthcare professional.  Complementing this approval, UCB Japan will launch a home delivery service for Rystiggo, including portable syringe pumps, as part of the ONWARD program. ONWARD is a global UCB patient support program designed to assist individuals living with rare diseases like gMG, offering features such as symptom tracking, support by dedicated Care Coordinators for each patient, and 24/7 online tools.

"For people living with gMG, unpredictable symptoms can significantly impact daily life, leading to feelings of vulnerability and loss of control. Subcutaneous self-administration can help address these challenges, providing better control over treatment schedules and enhancing autonomy and satisfaction," said Donatello Crocetta, Chief Medical Officer and Head of Global Medical Affairs. "We are delighted to achieve this approval in Japan and the roll out of the ONWARD home delivery service, which together provide personalized support and reduce the treatment burden for those affected by gMG."

Rystiggo was approved for the treatment of generalized myasthenia gravis gMG in adult patients (only for patients who are not adequately responsive to steroids or nonsteroidal immunosuppressants) in Japan in September 2023.

About ONWARD
ONWARD is a personalized support experience built to help people through every step of their prescribed UCB treatment. A key component of ONWARD program is being assigned their own dedicated Care Coordinator who provides tailored support based on an individual’s unique needs. The program is not intended for diagnosis, treatment, or equivalent medical acts. Registration information is strictly managed by UCB's subcontractors, and UCB does not have access to personally identifiable information.