PARIS (dpa-AFX) - Sanofi (SNY, SAN.PA) said The Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent or dupilumab for the treatment of bronchial asthma in children aged 6 to 11 years with severe or refractory disease whose symptoms are inadequately controlled with existing therapy. This expands the previous approval in Japan in this indication for patients aged 12 years and older.
The approval is based on data from the overall population and those with a type 2 inflammation phenotype in VOYAGE, a global phase 3 study evaluating Dupixent in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma.
Dupilumab is being jointly developed by Sanofi and Regeneron (REGN) under a global collaboration agreement.
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