China’s National Medical Products Administration (NMPA) has approved for Zai Lab and Argenx‘s efgartigimod alfa subcutaneous injection (efgartigimod SC), 1,000mg (5.6ml)/vial for the treatment of generalised myasthenia gravis (gMG).
The asset is indicated as an add-on to standard treatment for use in adults with gMG who are anti-acetylcholine receptor antibody positive.
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The biologics licence application (BLA) for efgartigimod alfa injection was supported by positive data from the international Phase III ADAPT-SC clinical trial.
This was a bridging study to the Phase III ADAPT trial, which was the foundation for the approval of intravenous VYVGART in adult gMG patients.
The ADAPT-SC study met its primary endpoint of noninferiority with efgartigimod SC showing a mean total IgG reduction of 66.4% from baseline at day 29 against 62.2% with efgartigimod IV.
Key secondary endpoints were also met, demonstrating consistency with efficacy measures from the ADAPT study that correlated total IgG reduction with clinical benefit in gMG.
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By GlobalDataEfgartigimod SC’s safety profile aligned with findings from the ADAPT study.
It was generally well-tolerated with the most common adverse event being injection site reactions (ISRs).
Beyond gMG, efgartigimod SC is under evaluation for the treatment of additional autoimmune disorders.
Under an exclusive licence agreement, Zai Lab is responsible for the development and marketing of efgartigimod in mainland China, Hong Kong, Macau and Taiwan, collectively referred to as Greater China.
Zai Lab global research and development president and head Rafael Amado stated: “We are pleased to receive NMPA approval for efgartigimod SC, marking an important milestone as we bring another first-in-class option to gMG patients in China.
“The addition of a new treatment option for gMG patients enhances flexibility for patients, potentially further simplifying the regimen and making therapy more accessible within the community. We appreciate the NMPA for their thorough assessment and recognition of the therapy’s differentiated profile and the large unmet medical need in China.”
In May 2024, Zai Lab and Innoviva Specialty Therapeutics received China NMPA approval for XACDURO to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.
