Vyvgart approved to treat adults with gMG in China
The approval covers Vyvgart as an injectable add-on to standard therapy
Vyvgart (efgartigimod alfa) has been approved in China as an add-on to standard therapy for adults with generalized myasthenia gravis (gMG).
The approval, announced by the therapy’s developer Argenx and its partner Zai Lab, was made by the Chinese regulatory agency the National Medical Products Administration (NMPA). The approval is for gMG adults who are positive for acetylcholine receptor (AChR)-targeting antibodies, the most common type of MG-causing antibody.
The NMPA had accepted for review Zai Lab’s application requesting Vyvgart’s approval in China last year.
This is the sixth approval for Vyvgart in gMG, following similar decisions in the U.K., U.S., Japan, Israel and the European Union.
Zai Lab, which is responsible for the development and commercialization of Vyvgart in Greater China — encompassing the mainland, Hong Kong, Taiwan and Macau — following a 2021 agreement with Argenx, will now work with the National Healthcare Security Administration (NHSA) to include Vyvgart in the national reimbursement drug list (NRDL) in an effort to broaden patients’ access to treatment.
“We celebrate this achievement with our partner, Zai Lab, who shares our mutual passion to bring needed innovation to people with gMG in China. We look forward to continuing our partnership as we further explore efgartigimod in other indications, expanding our global footprint in one of the world’s fastest growing markets to reach more people living with severe autoimmune diseases,” Tim Van Hauwermeiren, Argenx’s CEO, said in a press release.
“There are over 200,000 people living with myasthenia gravis (MG) in China. Despite the availability of current treatment options, there remains a significant unmet medical need. The approval of Vyvgart in China marks an important milestone for patients and provides physicians with a novel, safe and effective therapy to help improve the quality of life for those in their care,” said Chongbo Zhao, MD, PhD. Zhao is deputy director of the department of neurology at Huashan Hospital, which is affiliated with Fudan University.
Self-reactive antibodies, or autoantibodies, that interfere with the communication between nerve and muscle cells are the key drivers of MG.
How Vyvgart works
Vyvgart is designed to lower the levels of MG-driving self-reactive antibodies by blocking the activity of the neonatal Fc receptor, a protein that normally helps stabilize and prevent the degradation of antibodies circulating in the bloodstream.
Patients initially receive four hour-long, into-the-vein (intravenous) infusions of Vyvgart given over the course of four weeks. Additional treatment cycles are given as needed based on a patient’s response.
“We are pleased to have the NMPA’s approval for Vyvgart for intravenous use. This important milestone brings forward a novel treatment for gMG patients who face many challenges living with this complex and difficult-to-control autoimmune disease,” said Samantha Du, PhD, Zai Lab’s founder and CEO.
Data from the Phase 3 ADAPT trial (NCT03669588), which compared the safety and effectiveness of Vyvgart against a placebo for about six months in 167 adults with gMG, supported the approval.
Results showed that Vyvgart, given as an add-on therapy, was more effective than a placebo at easing gMG symptoms, as showcased by clinically meaningful improvements in the scores of several measures of disease severity. Vyvgart also was found to be generally safe and tolerated well.
Open-label extension study
Patients who completed ADAPT had the option to start or continue treatment with Vyvgart in an open-label extension study, called ADAPT+ (NCT03770403).
At a mean follow-up of nearly two years, Vyvgart continued to ease symptoms across several measures of disease severity.
“In clinical studies, efgartigimod demonstrated outstanding characteristics in terms of onset of action, efficacy, and safety, helping to improve patients’ muscle strength and quality of life. Vyvgart, the first-and-only approved FcRn antagonist for gMG patients in China, has the potential to revolutionize the treatment landscape for gMG patients in China and we are grateful to Zai Lab for providing the support for these patients who have been devastated by this disease for so long,” Zhao said.
“In addition to gMG, we are working with argenx on three registrational programs exploring other … autoimmune indications and are looking forward to exploring even more indications over time,” Du said.
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