China-based Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced that the National Medical Products Administration (NMPA) has accepted for review a Biologics License Application (BLA) for Vyvgart (efgartigimod alfa) in subcutaneous injection form. The intended indication is for adult patients with generalized myasthenia gravis (gMG).
Exclusive Rights and Prior Approvals
Zai Lab holds exclusive development and commercialization rights to efgartigimod in mainland China, Hong Kong, Macau, and Taiwan (Greater China) through a license agreement with argenx (NASDAQ: ARGX), signed in July 2022. Vyvgart is the first approved FcRn blocker in the United States, EU, and China for the treatment of adults with gMG who are anti-acetylcholine receptor (AChR) antibody positive. It is also approved in Japan for the treatment of adults with gMG who do not have a sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). Vyvgart in IV injection form was already approved in China last week.
Priority Review Status and Phase III Results
Efgartigimod alfa subcutaneous injection was previously awarded priority review status in the US. The Phase III ADAPT-SC trial, which assessed the pharmacodynamics non-inferiority of the drug’s subcutaneous injection compared with intravenous infusion in gMG adult patients, has reached its primary endpoint. The trial demonstrated that the subcutaneous injection had a non-inferiority effect in reducing total IgG on day 29 compared to intravenous infusion. Compared to baseline levels, the subcutaneous injection showed an average total IgG reduction of 66.4% on day 29 (versus 62.2% for intravenous infusion), highlighting the potential benefits of the subcutaneous form for patients with gMG.-Fineline Info & Tech
