2 new home treatment methods for Rystiggo approved in Japan
gMG therapy can now be self-administered by patients via syringe or pump
Japan’s drug regulatory agency has authorized two new administration methods for Rystiggo (rozanolixizumab) — an approved treatment for generalized myasthenia gravis (gMG) — that people with the chronic autoimmune condition can use at home.
These approvals, by the Pharmaceuticals and Medical Devices Agency, or PMDA, will allow gMG patients in Japan to self-administer Rystiggo using either an infusion pump or a manual push syringe, developer UCB noted in a company press release. Patients must receive training from a healthcare professional on how to properly administer the therapy before they can do so themselves, the company noted.
According to UCB, these new home treatment methods will give back control to patients.
“For people living with gMG, unpredictable symptoms can significantly impact daily life, leading to feelings of vulnerability and loss of control,” said Donatello Crocetta, chief medical officer and head of global medical affairs at UCB. “Subcutaneous [or under-the-skin] self-administration can help address these challenges, providing better control over treatment schedules and enhancing autonomy and satisfaction.”
ONWARD program from UCB Japan will support home treatment
In tandem with the approvals, UCB Japan will now be offering a home delivery service for Rystiggo through ONWARD, the company’s global patient support program for people with myasthenia gravis (MG) and other rare diseases.
The ONWARD program offers services such as symptom tracking, individual support from dedicated care coordinators, and other online tools, according to the company. Information on financial support is also available on ONWARD.
“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,” Crocetta said.
An autoimmune disease, MG is driven by self-reactive antibodies that disrupt the communication between nerve and muscle cells. This leads to hallmark MG symptoms of muscle weakness and fatigue. People with generalized myasthenia gravis or gMG have a more severe form of the disease, often marked by systemic, or body-wide weakness.
Rystiggo works to block the activity of the neonatal Fc receptor (FcRn), a protein that normally helps prevent antibodies circulating in the bloodstream from being destroyed. By blocking FcRn, the therapy accelerates the rate at which antibodies are degraded, including the ones that drive MG, thereby easing disease symptoms.
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.
The therapy has been approved in Japan since 2023 for gMG patients who don’t adequately respond to steroids or nonsteroidal immunosuppressive agents.
In the U.S., Rystiggo is approved for adults with gMG who have antibodies against acetylcholine receptor (AChR) or muscle-specific tyrosine kinase (MuSK), the most common types of MG-driving antibodies. It’s also approved in the European Union as an add-on to standard treatment for adults with AChR- and MuSK-positive gMG.
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