Sanofi today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of Dupixent (dupliximab) for a sixth potential indication as a supplemental biologic.
Sanofi announced today that the U.S. Food and Drug Administration (FDA) has granted priority review of the Supplemental Biologics License Application (SBLA) for the sixth potential indication for dabigatran (duplizumab), an add-on maintenance treatment for adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The FDA approval is expected on June 27, 2024. China has also submitted a marketing authorization application and received acceptance from the Center for Drug Evaluation (CDE) of the State Drug Administration (SDA).

Data from two Phase III clinical trials (BOREAS and NOTUS) supporting this SBLA and other applications globally evaluated the efficacy and safety of Dupixent in adult patients with uncontrolled chronic obstructive pulmonary disease (COPD) with type 2 inflammation who are smokers or have a history of smoking and who are currently receiving the best available standard of care (triple combination therapy), both trials meeting their primary endpoints. both met their primary endpoints.

In the BOREAS and NOTUS trials, the incidence of acute exacerbations of moderate-to-severe COPD at 52 weeks was significantly reduced by 30% and 34% in the Dupixent® treatment group compared to the placebo group. Both trials showed that Dupixent® provided a rapid and significant improvement in lung function compared to placebo, and that this benefit was sustained through week 52.

In both trials, the safety profile of Dupixent® was generally consistent with its known safety profile in the approved indications. Back pain, COVID-19, diarrhea, headache and nasopharyngitis were the more common adverse reactions (>5%) in the Dupixent@ treatment group compared to the placebo group.

Priority review is typically granted to registration applications seeking approval of therapies that have the potential to provide a significant improvement in the treatment, diagnosis, or prevention of serious diseases. The potential use of Dupixent@ in chronic obstructive pulmonary disease is currently in clinical development, and its safety and efficacy for this indication have not been fully evaluated by any regulatory agency.

https://mp.weixin.qq.com/s/N-rLqyYJ62wcjDK5_GADZw