The US Food and Drug Administration (FDA) has granted approval to United States-based Regeneron Pharmaceuticals (NASDAQ: REGN) and France-based Sanofi for Dupixent (dupilumab) intended to treat adults with nasal polyps accompanied by chronic rhinosinusitis (CRSwNP), it was reported yesterday.

The approval enables the companies to use the product with other medicines for the treatment of chronic rhinosinusitis with nasal polyposis in adults whose disease is not controlled.

The product is a fully-human monoclonal antibody that blocks the signalling of interleukin-4 (IL-4) and interleukin-13 (IL-13), the proteins that play a significant role in type 2 inflammation. According to Regeneron, Dupixent clinical trials data showcased that inhibiting IL-4 and IL-13 helps address the type two inflammation.

The US FDA approval was based on two pivotal trials, the 24-week Sinus-24 and 52-week Sinus-52, which are part of the phase three Liberty clinical trial programme. The trials evaluated Dupixent 300mg every two weeks with standard-of-care mometasone furoate nasal spray compared against placebo injection plus mometasone furoate nasal spray. Dupixent significantly improved key disease measures and achieved all primary and secondary endpoints in these trials.

Dupixent is available in a 300mg pre-filled syringe for patients with CRSwNP, and is administered as a subcutaneous injection every other week at different injection sites.