French pharmaceutical major Sanofi (NASDAQ: SNY) has announced that it has received priority review status from the Center for Drug Evaluation (CDE) for its Dupixent (dupilumab) to treat prurigo nodosa (PN) in adults. This marks another significant breakthrough in the type 2 inflammation field, following the drug’s indication approval for the treatment of moderate to severe atopic dermatitis (AD) in children and adults aged six years and above.
Disease Background and Impact
Prurigo nodosa is a chronic disease characterized by severe, hard, and pruritic papular nodular lesions, which typically occur on the trunk and limb extensions. Compared to other chronic pruritic diseases, PN has a more significant impact on the quality of life and increases the risk of mental and psychological comorbidities. The priority review status awarded to Dupixent is based on the positive results of the Phase III PRIME and PRIME 2 studies.
Clinical Trial Results
A total of 311 patients were enrolled in the trials, with 50% having a past or current history of atopic comorbidities (such as atopic dermatitis). Both trials reached their primary and critical secondary endpoints. At 12 weeks, 44% and 37% of the patients in the PRIME and PRIME 2 trials, respectively, achieved 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 was three times that of the placebo group, and the proportion of patients who achieved skin lesion clearance or almost clearance was more than two times that of the placebo group.
Dupixent’s Mechanism and Regulatory History
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 AD in June 2020. It was subsequently included in the National Reimbursement Drug List (NRDL) later that year. The drug’s approval was expanded to treat AD in adolescents aged 12 and above and adults in September 2021, and further expanded to include children aged six and older and adults in February of this year.
Future Prospects
The priority review status for Dupixent in prurigo nodosa indicates the potential for this innovative therapy to address a significant unmet medical need. With its proven efficacy in atopic dermatitis and now prurigo nodosa, Dupixent continues to demonstrate its value in treating type 2 inflammatory diseases, offering hope to patients suffering from these conditions.-Fineline Info & Tech
