"Duprizumab" for the treatment of adult nodular itching was recommended by the European Union
On November 11, Sanofi/Shengsheng Yuan jointly announced that the European Medicines Agency (EMA) Human Medicines Committee (CHMP) had released its positive opinion on the marketing approval of Dupixent (dupilumab, Duprizumab) for the treatment of adult patients with moderate to severe prurigo nodosa. The European Commission will make a final decision on the marketing application in the next few months.
Patients with prurigo nodosa will experience intense and persistent itching, accompanied by thick skin lesions (called nodules), which can cover most of the body. Due to extreme itching, the uncontrolled diagnosis of nodular itching has the highest impact on the quality of life of patients with inflammatory skin diseases, which is equivalent to other debilitating chronic diseases that may have a negative impact on mental health, daily life and social interaction.
Duprizumab is the first biological agent in the field of dermatology, respiratory medicine and allergy medicine. At present, the indications approved for marketing include atopic dermatitis, asthma, eosinophilic esophagitis (for patients aged 12 years and above) and chronic rhinosinusitis with nasal polyps (CRSwNP).
On September 28, 2022, FDA approved the new indication application of Duprizumab for the treatment of adult prurigo nodosa. This is the world's first and only drug specifically used to treat prurigo nodosa.
This CHMP recommendation is based on the positive data of two randomized, double-blind, placebo-controlled Phase III PRIME and PRIME2 trials. PRIME and PRIME2 studies were conducted to evaluate the efficacy and safety of Duprizumab in the treatment of adult patients with prurigo nodosa.
The PRIME study included 151 adult patients with prurigo nodosa, including those with poorly controlled or inadvisable local prescription treatments. The primary end point was to assess the proportion of patients with clinically significant improvement in itching symptoms at 24 weeks (measured by a reduction of ≥ 4 points in the most severe itching score scale [WI-NRS]). The key secondary endpoint was the proportion of patients with skin clearance or almost clearance at 24 weeks (measured by 0 or 1 point on the investigator's global assessment pn phase [IGA PN-S] 0-4 scale).
The results showed that the trial reached the primary and key secondary end points, Dupixent could significantly improve the signs and symptoms of the disease, including the reduction of itching and skin lesions. At 24 weeks, 60% of Dupixent treated patients experienced a clinically significant reduction in pruritus, compared with 18% in the placebo group (p<0.0001); In addition, 48% of patients in the treatment group had skin symptoms cleared or almost cleared, compared with 18% of patients in the placebo group (p=0.0004). The safety results of this test are basically consistent with previous studies.
A total of 160 subjects were included in PRIME2 study, which were divided into two groups, Duprizumab group (n=78) and placebo group (n=82). The results showed that at week 12, 37% of patients in the Duprizumab treatment group had clinically significant reductions in itching compared with baseline, while only 22% in the placebo group (p=0.0216). At the 24th week, 58% of patients in Duprizumab treatment group had clinically significant itching reduction compared with baseline, while only 20% in placebo group (p<0.0001); In addition, 45% of patients in the treatment group had skin symptoms cleared or almost cleared, while only 16% in the placebo group (p<0.0001). The patients' quality of life, skin pain, anxiety and depression symptoms were significantly improved.
Sanofi's trump card is Dupixent. In 2021, the sales volume of this product will increase by 52.7%, reaching 5.249 billion euros. In the first half of 2022, the revenue of 3577 million euros was realized, with a year-on-year growth of 44.4%, including a year-on-year growth of 61% in Q2.
With the continuous increase of Dupixent's clinical indications and the continuous expansion of the market, this drug will become the second best-selling anti-inflammatory drug in the world after Umira. Sanofi believes that its peak sales in the future will exceed 13 billion euros. This figure does not include its potential to further improve the sales target in the indication of chronic obstructive pulmonary disease (COPD). It is expected that key data will be released in 2023.