UCB, a global biopharmaceutical company, has announced the CHMP (Committee for Medicinal Products for Human Use) has issued a positive opinion for the self-administration of RYSTIGGO (rozanolixizumab) via an infusion (syringe pump) or a new manual push syringe method, after training from a healthcare professional.
In the EU, rozanolixizumab is indicated as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody-positive.
“For people living with gMG, unpredictable symptoms can have a significant impact on daily life, leading to patients feeling vulnerable and lacking control. Subcutaneous self-administration may help address these challenges, enhancing patient autonomy and satisfaction by reducing the need for frequent clinic visits,” said Donatello Crocetta, Chief Medical Officer and Head of Global Medical Affairs, UCB. “We welcome the EU approval for self-administration of rozanolixizumab in Europe, marking another significant step forward in our ongoing commitment to improving the lives of people living with gMG.”
This approval is based on several studies, including a Phase 3, open-label, crossover study to evaluate the ability of patients with generalized myasthenia gravis (gMG) to successfully self-administer rozanolixizumab after training in the self-administration technique using the syringe driver and manual push methods. The manual push method allows administration at a flow rate that is comfortable for the patient to accommodate individual preferences. In clinical trials, infusion times by manual push for rozanolixizumab ranged from 1 to 30 minutes with a median infusion time of just 5 minutes per patient.
Self-administration of rozanolixizumab is also being reviewed by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
Currently, rozanolixizumab is administered by the patient’s clinician as a subcutaneous infusion once weekly for six weeks using infusion pump/syringe pumps, and the recommended total weekly dose of rozanolixizumab is based on the patient’s body weight.
