Pharmaceutical Technology

FDA to decide on Sanofi/Regeneron’s Dupixent for COPD in June

Sanofi and Regeneron’s Dupixent has received priority review by the US FDA, with a target action date of 27 June.

Sanofi and Regeneron are close to adding chronic obstructive pulmonary disease (COPD) as the sixth indication for its blockbuster therapy Dupixent (dupilumab).

The US Food and Drug Administration (FDA) has granted priority review for a supplemental biologics licence application (sBLA) for Dupixent as an add-on maintenance treatment for certain adult patients with uncontrolled COPD. The agency has set a target date of 27 June 2024.

Dupixent, a monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, is already approved to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis.

As per Regeneron’s financials, Dupixent pulled in $11.59bn in global sales in 2023. GlobalData forecasts the therapy revenue to maintain its upward trajectory and generate $20.4bn in sales in 2030.

GlobalData is the parent company of Pharmaceutical Technology.

Dupixent’s sBLA is supported by data from the Phase III NOTUS study (NCT04456673) and the Phase III BOREAS study (NCT03930732). In November 2023, the companies reported that an interim analysis from the NOTUS trial showed that patients with COPD who were treated with Dupixent demonstrated a 34% reduction in moderate or severe exacerbations at 52 weeks. The published data from the BOREAS trial also showed that Dupixent resulted in a 30% reduction in moderate or severe acute COPD exacerbations over 52 weeks.

Sanofi and Regeneron are also engaging with regulatory bodies in China and the European Union. Dupixent is currently under review as an add-on maintenance treatment in certain adult patients with uncontrolled COPD by two regulatory agencies, namely China’s National Medical Products Administration (NMPA) and the European Commission.

While Dupixent is making strides in COPD, it fell short for the treatment of chronic spontaneous urticaria (CSU) when the FDA rejected the sBLA for the therapy in October 2023, stating that more efficacy data was needed to support Dupixent’s approval in CSU. However, Sanofi and Regeneron plan to resubmit the sBLA, supplemented by data from the Phase III LIBERTY-CUPID Study C trial (NCT04180488). Results from the trial are expected in late 2024.

Although last week, Dupixent was approved as a treatment for chronic spontaneous urticaria (CSU) in patients aged 12 years and older by the Japanese Ministry of Health, Labor and Welfare