European Commission approves Sanofi’s Dupixent in chronic rhinosinusitis with nasal polyposis
pharmafile | October 30, 2019 | News story | Research and Development, Sales and Marketing | Dupixent, EU, Sanofi, pharma
Sanofi’s Dupixent (dupilumab) has secured European approval for the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP), it has emerged.
The approval relates specifically to severe forms of the condition in adults who have not seen adequate disease control from systemic corticosteroids or surgery. Patients affected by CRSwNP can experience persistent difficulties breathing, facial pressure, and reduced sense of smell due to blockages in the nasal passages and sinuses.
The European Commission based its decision on Phase 3 data drawn from two studies – a 24-week trial and a 52-week trial – demonstrating that Dupixent plus standard-of-care intranasal corticosteroids improved nasal congestion severity by 57% and 51% respectively compared to 19% and 15% with placebo plus standard-of-care intranasal corticosteroids. The combo also reduced patient nasal polyp scores by 33% and 27% compared to 7% and 4% increase with placebo. Both measures were primary endpoints of the study, which the combo met in both instances.
The trials also showed that the Dupixent combo led to a 42% and 27% improvement in sinus opacification compared to 4% and 0% with the placebo combo, and improved loss of smell by 52% and 45% compared to 12% and 10%.
“People living with severe CRSwNP, are often desperate to find new treatment options given that current standard treatments such as intermittent courses of systemic corticosteroids or sinonasal surgery are associated with disease recurrence,” remarked Dr George D Yancopoulos, President and Chief Scientific Officer at Regeneron. “Dupixent significantly improved the signs and symptoms of severe CRSwNP, and also eliminated the need for further surgery or corticosteroid use in approximately three-quarters of patients. Today’s approval provides patients in Europe with the first biologic treatment to address the type 2 inflammation that underlies most CRSwNP. This is the third type 2 disease in which Dupixent has been approved, and we continue to investigate Dupixent in a broad range of type 2 inflammatory diseases.”
Dr John Reed, Sanofi’s Global Head of Research and Development, added: “Many patients with CRSwNP have co-morbid asthma, and those patients tend to have more severe disease that is often more difficult to treat. These particular patients may have an increased risk of asthma attacks, high symptom burden and a substantial adverse impact on health-related quality of life. Nearly 60% of the patients in the CRSwNP trials had asthma, and the data showed Dupixent provided an additional benefit of improved lung function in these patients.”
Matt Fellows
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