Sanofi's Dupilumab Approved for 7th Indication in China: COPD Breakthrough with Potential Side Effects

On September 27, 2024, Sanofi, a leading biopharmaceutical company, announced that its prominent drug, dupilumab, has received approval from China's National Medical Products Administration (NMPA). This approval signifies that dupilumab will now be available for adult patients in China suffering from chronic obstructive pulmonary disease (COPD) with elevated blood eosinophils, particularly when traditional treatments have proven inadequate. This milestone represents dupilumab's seventh approved indication in China, playing a critical role in Sanofi's global strategy for expanding the drug's applications.

Dupilumab, developed in collaboration with Regeneron, is a fully human monoclonal antibody targeting the IL-4/IL-13 pathway. By inhibiting the signaling pathways mediated by these key cytokines, dupilumab effectively disrupts the cycle of Th2 inflammatory responses. This mechanism forms the basis for its effectiveness and safety across various inflammatory diseases, including COPD.

Dupilumab's journey in the Chinese market began years ago with approvals for multiple conditions. Initially, it was authorized for treating moderate to severe atopic dermatitis in patients of all ages, from infants to adults. It also gained approval for treating moderate to severe nodular pruritus in adults, and for the maintenance treatment of asthma in adolescents and adults aged 12 and above. These approvals have solidified dupilumab's reputation and laid the groundwork for its use in COPD treatment.

The international recognition of dupilumab's efficacy in COPD is evident. On July 3 of this year, the European Medicines Agency (EMA) also approved dupilumab as an additional treatment for COPD patients with elevated blood eosinophil levels. This global acknowledgment reinforces dupilumab's leading position in COPD treatment.

The foundation for the approval of dupilumab for COPD comes from two major clinical studies: the BOREAS study and the NOTUS study. Both were large, multicenter, randomized, double-blind, placebo-controlled trials. The BOREAS study involved 939 COPD patients and demonstrated that dupilumab significantly reduced the frequency of moderate to severe acute COPD episodes by 30% over 52 weeks. This reduction was statistically significant compared to the placebo group (p<0.001). Additionally, dupilumab markedly improved lung function, increasing the forced expiratory volume in one second (FEV1) by 160mL from baseline at week 12, whereas the placebo group saw an increase of only 77mL (p<0.001).

The NOTUS study, which included 935 COPD patients, confirmed dupilumab's superiority. Patients treated with dupilumab experienced a 34% reduction in acute COPD episodes over 52 weeks, and their FEV1 improved by 139mL compared to 57mL in the placebo group (p<0.001). These compelling results provide strong evidence supporting dupilumab's clinical application for COPD and offer new therapeutic hope for patients with this challenging condition.

In summary, the approval of dupilumab for COPD in China marks a significant advancement in the treatment of this disease. Its proven efficacy in reducing acute episodes and improving lung function, backed by robust clinical data, underscores dupilumab's potential as a valuable treatment option for COPD patients worldwide. This milestone not only enhances Sanofi's presence in the Chinese market but also strengthens dupilumab's position as a leading therapeutic solution for inflammatory diseases globally.