Telitacicept OK’d in China for adults with AChR-positive generalized MG
Developer calls newly approved therapy 'a new and more powerful weapon'
Remegen’s telitacicept has been approved in China as an add-on treatment for adults with generalized myasthenia gravis (gMG) who are positive for antibodies targeting the acetylcholine receptor (AChR) — that’s approximately 80% of all gMG patients, per the company.
The decision, by the country’s National Medical Products Administration (NMPA), “fills the gap of domestic innovative drugs in the field of MG treatment in China,” Remegen said in a company press release.
“The approval of the MG indication for telitacicept in China is of great significance,” said Jianmin Fang, PhD, Remegen’s CEO. “It provides clinicians with a new and more powerful ‘weapon’ to treat patients more effectively and precisely.”
The release noted that telitacicept had been “included in the breakthrough therapy category and priority review by the NMPA.”
“We look forward to the inclusion of this indication in the medical insurance system to help patients and their families reduce the burden of treatment and further improve their quality of life,” Fang said.
Myasthenia gravis (MG) is an autoimmune disease in which self-reactive antibodies, or autoantibodies, disrupt the communication between nerve and muscle cells. This leads to symptoms of muscle weakness and fatigue.
The most common cause of MG is antibodies that target the AChR protein. According to Remegen, at least 4 of every 5 people with MG are positive for anti-AChR antibodies.
Antibodies are immune proteins made by B-cells, a type of immune cell. Telitacicept is designed to block the activity of two proteins — B-cell stimulator (BLyS) and A proliferation-inducing ligand (APRIL) — that play key roles in B-cell development and activation. By inhibiting these proteins, the therapy aims to reduce the activity of antibody-producing B-cells, thus reducing the levels of MG-driving antibodies.
Phase 3 trial in China assessed telitacicept’s safety, efficacy
A Phase 3 clinical trial (NCT05737160) conducted in China assessed the safety and efficacy of telitacicept in 114 adults with gMG. Participants were randomly assigned to receive either telitacicept or a placebo once per week for about six months. The therapy is given by subcutaneous, or under-the-skin, injection.
The study’s main goal was to evaluate the impact of treatment on scores on the MG Activities of Daily Living (MG-ADL) scale, a standardized measure of MG severity that assesses how much the disease is causing problems in day-to-day life.
Trial results, presented last month, showed that average MG-ADL scores dropped — marking an improvement — by more than five points for patients given telitacicept, compared with less than a point for those on the placebo.
Telitacicept demonstrated rapid and significant clinical improvements in the Phase [3] trial with good tolerability.
In more than 98% of patients given telitacicept, MG-ADL scores improved by at least three points, whereas such improvements were seen in 12% of patients in the placebo group. According to Remegen, telitacicept had the highest MG-ADL response rate of any gMG therapy that has completed Phase 3 testing.
“Telitacicept demonstrated rapid and significant clinical improvements in the Phase [3] trial with good tolerability,” said Yin Jian, the trial’s principal investigator from Beijing Hospital.
Jian added the trial findings provide “a high-profile basis for evidence-based clinical application of telitacicept in the treatment of MG, and has also opened up a new paradigm of precise treatment in this field.”
Telitacicept is now being tested in a separate Phase 3 study called RemeMG (NCT06456580), ongoing at sites in the U.S. and Poland. The study is open to adults with gMG who are positive for antibodies against AChR or muscle-specific kinase (MuSK).
Like the trial in China, participants will be randomly assigned to receive subcutaneous injections of telitacicept or a placebo, with the main goal of evaluating changes in MG-ADL scores. As of January, the study was still recruiting participants at several U.S. sites.
In China, telitacicept has previously been approved for two other autoimmune diseases that are mediated by B-cells and autoantibodies: systemic lupus erythematosus and rheumatoid arthritis.
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