Dupixent FDA review pending for adolescent chronic sinus disease

The US Food and Drug Administration (FDA) has accepted a supplemental biologics license application (sBLA) submitted by Regeneron and Sanofi for their immunology drug Dupixent (dupilumab), aiming to expand its use to adolescents aged 12 to 17 with chronic rhinosinusitis with nasal polyposis (CRSwNP). This chronic inflammatory condition often leads to breathing difficulties, nasal congestion, and impairments in smell and taste. The target decision date set by the FDA is September 15, 2024, marking a four-month acceleration from the standard review timeline due to the priority review status granted to this application.

If approved for this new indication, Dupixent would become the first drug sanctioned in the United States for treating adolescents with CRSwNP. The drug already holds approval for adult patients with the same condition, as well as for a range of other indications including atopic dermatitis, asthma, and eosinophilic esophagitis.

CRSwNP is often associated with other type 2 inflammatory diseases such as asthma. Dupixent operates as a monoclonal antibody that inhibits the signaling of interleukin-4 and interleukin-13, cytokines that are crucial players in inflammation processes.

The FDA’s decision will hinge on efficacy data derived from two pivotal trials, SINUS-24 and SINUS-52, which involved adult participants. Additionally, the sBLA includes safety data related to Dupixent's usage in other conditions for which it is already approved among adolescents.

Since its initial approval in 2017 for atopic dermatitis, Dupixent has been administered via injection and has progressively been approved for more conditions. The drug has shown significant sales growth, reaching $11.59 billion in 2023, a 33% increase from the previous year. Market analysts anticipate that Dupixent’s revenue will continue to rise, potentially hitting $22.7 billion annually by 2030.

Regeneron and Sanofi have a longstanding collaboration, having commenced their partnership on antibodies 16 years ago. They are also conducting Phase III clinical trials to explore Dupixent's efficacy in treating other conditions such as chronic spontaneous urticaria and chronic pruritus of unknown origin.

In addition to the CRSwNP indication, another potential approval is on the horizon for Dupixent. The FDA is expected to make a decision by the end of the upcoming month regarding its use in patients with chronic obstructive pulmonary disease (COPD) characterized by type 2 inflammation. This application, similar to the CRSwNP indication, has also been granted priority review status.

Dupixent’s success and expanding indications underscore the potential of monoclonal antibodies in treating a range of chronic inflammatory conditions, offering new hope for patients with limited treatment options. The forthcoming FDA decisions could further broaden the drug’s impact on public health, especially among younger patients suffering from complex inflammatory diseases.