(Health Korea News / Lee Chang-yong) The blockbuster atopic dermatitis treatment drug ‘Dupixent’, which sold 11.6 billion dollars (about 15.6 trillion won) last year, is expected to expand its indications to chronic urticaria.
Sanofi and Regeneron Pharmaceuticals announced on the 11th (local time) that in a phase 3 clinical trial administering ‘Dupixent’ to patients with CSU (Chronic spontaneous urticaria), itching, overall symptoms, and complete response rate improved.
The subjects of this clinical trial were 151 children and adults with CSU. Of these, 74 received ‘Dupixent’ and H1 antihistamine for 24 weeks. The remaining 77 received placebo and H1 antihistamine at the same time.
As a result, the itching score of patients administered ‘Dupixent’ decreased by an average of 8.64 points, while the placebo group decreased by 6.10 points (p=0.02). The urticaria activity (itching and urticaria) score of the ‘Dupixent’ group decreased by an average of 15.86 points, while the placebo group decreased by 11.21 points (p=0.02).
Sanofi explained that 30% of patients treated with ‘Dupixent’ reported complete disappearance of hives, which is a remarkable result. The complete response rate in the placebo group was 12% lower at 18% (p=0.02).
The p value is a value that evaluates the chance in a study, and it is considered statistically significant if it is lower than 0.05. The p value of the Dupixent group and the placebo group is 0.02, which means that the probability that the difference between the two groups occurred by chance is 0.2%.
“Patients with chronic spontaneous urticaria (CSU) suffer from severe, disruptive itching and hives that come on suddenly and can be very disruptive to their lives,” said George D. Yancopoulos, M.D., president and CEO of Regeneron. “These Phase 3 results support the potential of Dupixent to help relieve symptoms of this chronic inflammatory skin disease.”
If Dupixent is approved by the FDA, it will be the first new CSU treatment in 10 years. Currently, the only CSU treatment approved by the FDA is Novartis’ Xolair. Xolair, which had sales of $4 billion (about 5.3 trillion won) last year, is expected to face competition from biosimilars soon as its drug patent expires.
Earlier, ‘Dupixent’ successfully expanded its CSU indications in Japan earlier this year. Therefore, it is expected that this will be a factor leading to FDA approval in conjunction with the results of this phase 3 trial.
Meanwhile, Sanofi attempted to expand the indication of ‘Dupixent’ to CSU in October last year, but was rejected by the FDA.
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