PARIS (dpa-AFX) - Drug makers Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Wednesday that ADEPT study of Dupixent (dupilumab) in bullous pemphigoid or BP met the primary and all key secondary endpoints evaluating its investigational use in adults with moderate-to-severe disease.
The companies said the study will support regulatory submissions around the world, starting with the U.S. later this year. If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S. and European Union.
In addition, a small separate phase 3 study or Study A evaluating the investigational use of Dupixent in adults with uncontrolled and severe chronic pruritus of unknown origin (CPUO) did not achieve statistical significance in its primary itch responder endpoint. But it showed nominally significant improvements in all other itch endpoints.
BP is a chronic and relapsing disease, and is characterized by intense itch and blisters, reddening of the skin, and painful chronic lesions.
According to them, Dupixent is the first and only biologic to achieve significant improvements in disease remission and symptoms in BP positive pivotal study. Dupixent was previously granted Orphan Drug Designation by the U.S. Food and Drug Administration for BP.
In the ADEPT study, 106 adults with moderate-to-severe BP were randomized to receive Dupixent 300 mg every two weeks after an initial loading dose or placebo, along with standard-of-care OCS.
In the trial, five times more Dupixent patients achieved sustained disease remission compared to those on placebo. For the primary endpoint, 20% of Dupixent patients experienced sustained disease remission at 36 weeks compared to 4% for placebo.
George Yancopoulos, Board co-Chair, President, and Chief Scientific Officer at Regeneron, said, 'Bullous pemphigoid is a debilitating skin disease with a high mortality rate due to infection. Dupixent is the first medication to show significant and robust impacts in this patient population. These latest pivotal results reaffirm the underlying role type-2 inflammation plays in driving multiple skin diseases.'
The safety and efficacy of Dupixent in BP and CPUO are currently under clinical investigation and have not been evaluated by any regulatory authority.
Dupixent has received regulatory approvals in more than 60 countries in one or more indications. These include atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease in different age populations.
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