Sanofi and Regeneron’s Dupixent (dupilumab) has been approved by the US Food and Drug Administration (FDA) to treat bullous pemphigoid (BP) in adults.
The drug is now the only targeted medicine approved in the US to treat the chronic and relapsing skin disease, the partners outlined.
Approximately 27,000 adults in the US are living with BP that is uncontrolled by systemic corticosteroids. The condition mainly affects older adults and is characterised by intense itch, painful blisters and lesions, as well as reddening of the skin.
Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways, shown in the Dupixent development programme to be central drivers of the type 2 inflammation that plays a major role in multiple related diseases, including BP.
The approval was supported by results from the phase 2/3 ADEPT trial, which randomised 106 adults with moderate-to-severe BP to receive Dupixent 300mg or placebo added to standard-of-care oral corticosteroids.
The study met its primary endpoint, with 18.3% of Dupixent-treated patients experiencing sustained disease remission compared to 6.1% of those in the placebo group at 36 weeks.
At the same time point, 38.3% of patients being treated with Dupixent achieved clinically meaningful itch reduction compared to 10.5%, and oral corticosteroid use was lower in the Dupixent group.
Alyssa Johnsen, global therapeutic area head, immunology and oncology development at Sanofi, said: “Until now, treating BP was very challenging for elderly patients struggling with the debilitating impact of blisters and lesions, and potentially co-morbid conditions.
“By addressing two central drivers of the underlying type 2 inflammation that contributes to BP, Dupixent is the first targeted medicine to allow patients the potential to achieve sustained remission and reduce itch.”
Beyond BP, Dupixent is approved in the US for certain cases of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic oesophagitis, prurigo nodularis, chronic obstructive pulmonary disease and chronic spontaneous urticaria.
“This approval extends the remarkable ability of Dupixent to transform treatment paradigms for people living with a variety of diseases with underlying type 2 inflammation, from common conditions like asthma and atopic dermatitis, to rarer ones such as eosinophilic oesophagitis and prurigo nodularis, and now including BP,” said George Yancopoulos, president and chief scientific officer at Regeneron.