Sanofi and Regeneron have big ambitions for immunology superstar Dupixent—envisioning the potential for $11 billion in annual sales.
In acing a test in people with the debilitating itch condition prurigo nodularis, the companies may well be on their way to adding another indication for the versatile antibody treatment.
In the phase 3 trial, Dupixent significantly reduced itch at 12 weeks. Over 24 weeks, the drug was three times more effective than placebo in reducing itch and skin lesions.
PN is an inflammatory skin condition which produces a rash on the arms, legs, back and abdomen. It can be so severe that it interferes with sleep and psychological wellbeing. The underdiagnosed condition does not have an approved treatment option.
Topical steroids can combat the disorder to some degree, but 74,000 people in the United States need a more potent remedy, Regeneron says. PN most often strikes the elderly and is more prevalent in women. African Americans are three times more likely to have the disease.
Before the trial started, "nearly all patients had severe itch and nearly 40% had 100 or more nodules covering their body,” Sanofi’s R&D chief John Reed said in a statement. “These data are an important step forward in furthering our knowledge of the role that targeting IL-4 and IL-13 can play in the treatment of skin diseases that cause extreme itch.”
In the PRIME2 trial, which included 78 patients on Dupixent and 82 on placebo, 37% of those on Dupixent experienced a clinically meaningful reduction in itch at 12 weeks versus 22% of placebo patients. At week 24, 58% of Dupixent patients had a meaningful reduction in itch compared with 20% on placebo. Additionally, at 24 weeks, 45% of Dupixent patients achieved clear or almost clear skin versus 16% on placebo.
Dupixent patients also had greater improvements in symptoms of anxiety and depression. The most common adverse events were conjunctivitis and herpes viral infections, which each occurred in 6.5% of Dupixent patients compared to 0% for each condition for those on placebo.
Another PRIME trial, with a similar design, has been enrolled and is expected to read out in the first half of 2022. The companies plan to begin regulatory submissions in 2022.
Dupixent generated $4.1 billion in sales last year on the strength of approvals for eczema (2017), asthma (2018), atopic dermatitis in children (2019) and rhinosinusitis (2019). The companies are studying the drug for use in 10 other indications driven by type 2 inflammation including chronic pulmonary disease, eosinophilic esophagitis and chronic spontaneous urticaria. Of these 10 programs, nine are in phase 3.