The FDA approval of Dupixent is based on data from two Phase 3 PRIME and PRIME2 clinical trials, which evaluated the efficacy and safety of Dupixent in adults with prurigo nodularis
FDA approved Dupixent to treat Prurigo Nodularis. (Credit: Myriams-Fotos from Pixabay)
Sanofi and Regeneron Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved their Dupixent (dupilumab) to treat prurigo nodularis.
Prurigo nodularis is an inflammatory skin disease, characterised by a chronic skin disease with underlying type 2 inflammation that impacts the quality of life.
With the approval, Dupixent becomes the first and only therapy specifically indicated for the treatment of prurigo nodularis in the US.
The regulatory application for Dupixent in prurigo nodularis is evaluated under Priority Review, FDA’s fast-track status granted to eligible new drug submissions.
Regeneron president and chief scientific officer George D Yancopoulos said: “Patients living with prurigo nodularis must often contend with dozens, if not hundreds, of itchy and painful nodules covering their body and have not had an approved treatment option for their disease.
“Dupixent has already transformed the treatment landscape of several diseases driven by type 2 inflammation – including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis – and been prescribed to more than half a million patients around the world for its approved indications.
“With this approval, those suffering with prurigo nodularis finally have a medicine to address the debilitating signs and symptoms of the disease.”
The FDA approval is based on data from two Phase 3 PRIME and PRIME2 clinical trials, evaluating the efficacy and safety of Dupixent in adults with prurigo nodularis.
In the two clinical trials, the primary endpoint evaluated the proportion of patients with clinically meaningful improvement in itch from baseline at 24 and 12 weeks.
In the PRIME trial, 60% and 58% of participants taking Dupixent experienced a clinically meaningful reduction in itch from baseline at 24 weeks, which is the primary endpoint.
Also, 44% and 37% of patients on Dupixent experienced a clinically meaningful reduction in itch from baseline at 12 weeks, which is the primary endpoint in PRIME2.
The drug showed safety results that were generally consistent with the known safety profile of Dupixent in its approved dermatology indication.
The most common adverse events in both studies include nasopharyngitis, conjunctivitis, herpes infection, dizziness, muscle pain, and diarrhoea.
Sanofi immunology and inflammation global development head Naimish Patel said: “Dupixent has the potential to transform the standard-of-care for prurigo nodularis patients by alleviating the key hallmarks of the disease, such as reducing itch and achieving clearer skin.
“With Dupixent now approved in two diseases in dermatology where type 2 inflammation is a central driver, we look forward to further evaluating the potential of inhibiting IL-4 and IL-13 in other chronic skin diseases.”