The approval allows the drug firms to use Dupixent with other medicines for the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled.
CRSwNP is a chronic disease of the upper airway, which obstructs the sinuses and nasal passages. It leads to breathing difficulties, nasal congestion and discharge, reduced or loss of sense of smell and taste, and facial pressure.
Regeneron president and chief scientific officer Dr George Yancopoulos said: “Dupixent is the first FDA-approved medicine for adults with chronic rhinosinusitis with nasal polyposis, and the only approved therapy shown to shrink nasal polyp size and also improve the signs and symptoms of the associated chronic rhinosinusitis.
“In fact, approximately three-quarters of patients treated with Dupixent no longer required either corticosteroids or surgery, the current standards of care.”
Dupixent is a fully-human monoclonal antibody, which 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 demonstrated that inhibiting IL-4 and IL-13 helps address the type 2 inflammation, which plays a major role in CRSwNP, asthma and atopic dermatitis.
The FDA approval was based on two pivotal trials such as 24-week Sinus-24 and 52-week Sinus-52, which are part of the phase 3 Liberty clinical trial programme.
The trials assessed Dupixent 300mg every two weeks with standard-of-care mometasone furoate nasal spray (MFNS) compared against placebo injection plus MFNS.
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.
Sanofi research and development head Dr John Reed said: “Chronic rhinosinusitis with nasal polyposis can be a debilitating condition. Today’s standard of care – which includes intranasal and systemic corticosteroids and sinus surgery – often leaves patients with CRSwNP with recurring symptoms.