By Dina Kartit
(Reuters) -China’s National Medical Products Administration (NMPA) has approved Zai Lab Limited’s and Argenx SE’s Biologics License Application (BLA) for VYVGART, a treatment for generalised myasthenia gravis (gMG), muscle-weakening disease, in anti-body positive adults, the Dutch company said on Friday.
Generalized myasthenia gravis (gMG) is a chronic neuromuscular disease caused by an abnormal immune reaction that weakens the muscles in different parts of the body. Argenx said that about 200,000 people in China live with the disease.
The global Phase III ADAPT trial met its primary endpoint, Argenx said in a statement, adding that VYVGART demonstrated a well-tolerated safety profile in the trial.
The most commonly reported adverse reactions with VYVGART compared with placebo were upper respiratory tract infections and urinary tract infections, the Dutch company said.
“This approval by the NMPA for VYVGART, our sixth approval globally, is the first-and-only FcRn blocker available for people living with gMG in China,” said Argenx CEO Tim Van Hauwermeiren in a statement.
Zai Lab will now work with the National Healthcare Security Administration (NHSA) for National Reimbursement Drug List (NRDL) inclusion to enable broad access for patients, Argenx said.
On June 21, the U.S. Food and Drug Administration has also approved Argenx’s treatment for the treatment of a gMG, branded as Vyvgart Hytrulo, which is expected to be available in the country next month and will come at a list price of $15,773.
(Reporting by Dina Kartit, Editing by Louise Heavens)
