The European Commission (EC) has extended the marketing authorization for Dupixent (dupilumab) in the EU for the treatment of adults with moderate-to-severe pregigo nodularis who are candidates for systemic therapy.
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied in more than 60 clinical trials involving more than 10,000 different chronic diseases.
Prurigo nodularis is a chronic and debilitating skin disease with underlying type 2 inflammation and its impact on quality of life is one of the highest among skin diseases. With this approval, Dupixent is the first and only targeted drug in Europe and the US specifically targeted to treat preggo nodularis.
Lighten the load
Naimish Patel, head of global development, immunology and inflammation at Sanofi, said: “As the first and only targeted drug approved to treat people living with prygo nodularis, dupixent has the potential to transform standard of care for people living in Europe.” In this weak skin disease.
“In pivotal trials, patients treated with Dupixent experienced significant improvements in key disease symptoms, such as reduced itching and clearer skin, as well as broader effects on their daily lives. This approval of Dupixent underscores our commitment to bringing Dupixent to patients suffering from chronic skin disease as quickly as possible.”
George D’Iancopoulos, Regeneron’s president and chief scientific officer, added: “For the first time in Europe, Prichgo nodularis patients have found a drug that can help ease the burden of the itchy and painful bumps that cover their skin.” They affect their daily life physically and mentally.
“Dupixent is now generally approved for second-line dermatology and fourth-line disease. We are committed to further investigating this for diseases that may play a role in type 2 inflammation, such as chronic urticaria and chronic obstructive pulmonary disease.
The EC’s decision was based on data from two phase 3 trials in which 44% and 37% of Dupixent patients experienced a clinically meaningful reduction in itching at 12 weeks, compared to 16% and 22% for placebo. The improvement increased at 24 weeks, with approximately three times more Dupixent patients (60% and 58%) compared to placebo (18% and 20%) with a clinically meaningful reduction in itching.
In PRIME and PRIME2, twice as many Dupixent patients (48% and 45%) compared with placebo (18% and 16%) achieved clear or almost clear skin at 24 weeks. In addition, Dupixent significantly improved health-related quality of life by reducing skin pain and anxiety/depression symptoms at 24 weeks compared to placebo.
Dupixent has been granted an additional one-year marketing protection in the EU based on a CHMP recommendation that the drug provides a significant clinical benefit compared to existing treatments for prurigo nodularis.
About prurigo nodularis
Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation, and is one of the skin diseases that has the greatest impact on the patient’s quality of life due to the intense itching it causes. People with prigo nodularis experience severe, persistent itching of thick skin lesions (called nodules) that can cover most of the body.
The disease is often painful, with burning on the skin, seizures and negative impact on mental health, daily activities and social relationships. High-potency topical steroids are widely prescribed, but are associated with safety risks with long-term use. In Europe, around 70,000 adults living with pruritic nodularis need very new treatment options.
Dupixent is a subcutaneous (injection under the skin) injection at various injection sites. In the EU, for adults with prurigo nodularis, Dupixent at 300 mg every two weeks, followed by a loading dose. Available in 300 mg as both a pre-filled pen and a pre-filled syringe. Dupixent is intended for use under the direction of a healthcare professional and can be self-administered in a clinic or at home after training by a healthcare professional.
Dupixent is a fully human monoclonal antibody that blocks signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. Dupixent’s development program has shown significant clinical benefit in reducing type 2 inflammation in phase 3 trials, confirming that IL-4 and IL-13 are key and central drivers of type 2 inflammation in a multi-related and multifactorial manner. Associated diseases. These diseases include indications approved for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and prurigo nodularis, as well as eosinophilic esophagitis (EoE), a disease diagnosed in the European Union.
Dupixent has received regulatory approvals in one or more countries worldwide for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), or prurigo nodularis in various age groups. Dupixent is currently approved for one or more indications in more than 60 countries, including Europe, the US and Japan. More than 500,000 patients worldwide have been treated with Dupixent.
Dupilumab development program
In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in various diseases in phase 3 trials of type 2 inflammation or other allergic processes. These include pediatric EoE, atopic dermatitis of the hands and feet, chronic intractable urticaria-flu, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic pneumonia with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, Allergic fungal ration, allergic bronchitis, aspergillosis and bullous pemphigoid.
These uses of dupilumab are currently under clinical investigation, and its safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.