France-based pharmaceutical company Sanofi (NASDAQ: SNY) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) in China for its drug Dupixent (dupilumab), which is now approved to treat prurigo nodosa (PN) in adults. This makes Dupixent the first and only drug approved for this indication in China.
Positive Trial Results Lead to Approval
The approval is based on the positive results of the Phase III PRIME and PRIME 2 studies, which assessed the drug in terms of efficacy and safety in 311 PN patients. At 12 weeks, 44% and 37% of the patients in the PRIME and PRIME 2 trials, respectively, received clinically significant symptom relief, which was significantly better than that in the placebo group. At 24 weeks, the proportion of patients in the treatment group who achieved clinically significant symptom relief in the two trials was three times that of the placebo group, and the proportion of patients in the treatment group who achieved skin lesion clearance or almost clearance was more than two times that of the placebo group.
Dupixent’s Mechanism of Action and Previous Approvals
Dupixent is a monoclonal antibody (mAb) that targets the IL-4 and IL-13 pathways. The molecule was designated a drug in urgent clinical need in China in May 2019, and won its first market approval to treat moderate to severe atopic dermatitis (AD) in June 2020, going on to gain inclusion in the National Reimbursement Drug List (NRDL) later that year. The drug, approved to treat AD in adolescents aged 12 and above and adults in September 2021, expanded its indication to include children aged six and older and adults in February last year. Its AD indication regained the NRDL status this year.-Fineline Info & Tech
