Sanofi's New Drug Dupilumab Approved for 7th Indication in China: Major Breakthrough in COPD Treatment, but Negative Effects May Become a Concern!

On September 27, 2024, Sanofi, the world's leading biopharmaceutical company, officially announced that its blockbuster drug, dupilumab, has been successfully approved by the National Medical Products Administration (NMPA) of China. It marks that this innovative therapy will be officially applied to adult patients with chronic obstructive pulmonary disease (COPD) in China whose blood eosinophils are significantly elevated and the traditional treatment is not satisfactory. This approval is not only another milestone for Dupliumab in the Chinese market, but also an important part of its global indication expansion strategy, so far, Dupliumab has accumulated the 7th indication approval in China.

Dupliumab, a combination of Sanofi and Regeneron, is a fully human monoclonal antibody targeting IL-4/IL-13. It effectively blocks the vicious cycle of Th2 inflammatory response by accurately inhibiting the signaling pathway mediated by two key cytokines, IL-4 and IL-13, thereby alleviating the pathological process of Th2 inflammatory diseases at the source. This unique mechanism of action has enabled dupliuzumab to demonstrate superior efficacy and safety in the treatment of a variety of inflammatory diseases, including COPD.

Reviewing the journey of dupliumab in the Chinese market, its footprint has spread across multiple disease areas. As early as earlier, the drug has been approved in China for the treatment of adults, adolescents, children and infants of all ages of moderate and severe atopic dermatitis, as well as moderate to severe adults nodular pruritus and maintenance treatment of adolescents and adult asthma patients aged 12 years and above, the cumulative approved indications have reached 6. These successful clinical applications not only validate the wide applicability of dupliuzumab in the treatment of inflammatory diseases, but also lay a solid foundation for its expansion in the field of COPD.

It is worth noting that the approval of dupliumab in the field of COPD has also been recognized by international authorities. Just on July 3 of this year, the European Medicines Agency (EMA) also officially approved Dupriumab as an additional maintenance treatment option for uncontrolled COPD patients characterized by elevated blood eosinophilia levels, a decision that further solidifies dupriumab's leading position in the global treatment of COPD.

The key evidence for the approval of propriuzumab for COPD came from two large, multicenter, randomized, double-blind, placebo-controlled clinical studies - the BOREAS study and the NOTUS study. These two studies included 939 and 935 eligible COPD patients, respectively, and fully demonstrated the significant efficacy of dupriuzumab in the treatment of COPD through rigorous trial design and scientific data analysis.

Specifically, the BOREAS study showed that the frequency of acute episodes of moderate to severe COPD was significantly reduced by 30% over 52 weeks in patients treated with duprulizumab, a difference that was highly statistically significant compared to the placebo group (p<0.001). Dupliuzumab also significantly improved pulmonary function, with a 160mL increase in forced lung capacity in one second (FEV1) from baseline at week 12 compared with 77mL in the placebo group, again with a statistically significant difference (p<0.001).

The results of the NOTUS study further confirmed the superiority of dupriuzumab in the treatment of COPD. The study also showed that patients in the dupriuzumab group had a 34% reduction in the frequency of acute episodes of moderate to severe COPD over 52 weeks, and the improvement in FEV1 was also 139mL, compared with 57mL in the placebo group (p<0.001). These remarkable data not only provide strong evidence support for the clinical application of dupriulizumab in the field of COPD, but also bring new treatment hope and choice for the majority of COPD patients.