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Regeneron's Dupixent Meets Goals in Nasal Polyps Studies
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Sanofi (SNY - Free Report) announced that the two phase III studies on Dupixent for the indication of chronic rhinosinusitis with nasal polyps (CRSwNP) were successful.
The placebo controlled phase III trials, which evaluated Dupixent in adults with inadequately-controlled CRSwNP, met all their primary and secondary endpoints.
Dupixent significantly reduced nasal polyp size, nasal congestion severity and need for systemic corticosteroids and/or surgery
The study results show that patients treated with Dupixent added to a standard-of-care corticosteroid nasal spray experienced a 51% and 57% improvement in their nasal congestion/obstruction severity compared to a 15% and 19% improvement with only nasal spray at 24 weeks in both trials. Moreover, Dupixent-treated patients experienced a 27% and 33% reduction in their nasal polyps score compared to a 4% and 7% increase for placebo. Dupixent also met all secondary endpoints in both trials, which include demonstrating a significant reduction in the need for systemic corticosteroids or surgery, and improvements in smell and chronic rhinosinusitis symptoms.
The drug was also effective in improving lung function and asthma control in a pre-specified group of patients with comorbid asthma.
The detailed results from these trials will be submitted at a future medical meeting and will form part of the companies' regulatory submissions.
We note that Dupixent is already approved for the treatment of adult patients with moderate-to-severe atopic dermatitis.
Strong Dupixent sales drove Regeneron’s impressive second-quarter results. Label expansion of approved drugs will further boost sales. The company and partner Sanofi are also working to expand Dupixent’s label, which should diversify the company’s revenue base and reduce dependence on the lead drug, Eylea. Regeneron and Sanofi are evaluating Dupixent in a broad range of clinical development programs for diseases driven by allergic or type 2 inflammation, including asthma (under regulatory review), pediatric asthma (phase III), pediatric atopic dermatitis (phase III), adolescent atopic dermatitis (phase III), eosinophilic esophagitis (phase III), grass allergy (phase II) and peanut allergy (phase II).
The companies are also planning to evaluate Dupixent in chronic obstructive pulmonary disease. Moreover, Dupixent is also being studied in combination with REGN-3500, which targets IL-33.
The FDA had earlier approved a supplemental Biologics License Application (sBLA) for Eylea injection in patients with wet age-related macular degeneration (wet AMD). Regeneron has co-developed Eylea with the HealthCare unit of Bayer AG (BAYRY - Free Report) .
Regeneron is working to expand its portfolio. The company and partner Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) also announced positive top-line results from a phase III study on pipeline candidate, fasinumab in patients suffering from chronic pain from osteoarthritis (OA) of the knee or hip.
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Regeneron's Dupixent Meets Goals in Nasal Polyps Studies
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Sanofi (SNY - Free Report) announced that the two phase III studies on Dupixent for the indication of chronic rhinosinusitis with nasal polyps (CRSwNP) were successful.
The placebo controlled phase III trials, which evaluated Dupixent in adults with inadequately-controlled CRSwNP, met all their primary and secondary endpoints.
Dupixent significantly reduced nasal polyp size, nasal congestion severity and need for systemic corticosteroids and/or surgery
The study results show that patients treated with Dupixent added to a standard-of-care corticosteroid nasal spray experienced a 51% and 57% improvement in their nasal congestion/obstruction severity compared to a 15% and 19% improvement with only nasal spray at 24 weeks in both trials.
Moreover, Dupixent-treated patients experienced a 27% and 33% reduction in their nasal polyps score compared to a 4% and 7% increase for placebo. Dupixent also met all secondary endpoints in both trials, which include demonstrating a significant reduction in the need for systemic corticosteroids or surgery, and improvements in smell and chronic rhinosinusitis symptoms.
The drug was also effective in improving lung function and asthma control in a pre-specified group of patients with comorbid asthma.
The detailed results from these trials will be submitted at a future medical meeting and will form part of the companies' regulatory submissions.
We note that Dupixent is already approved for the treatment of adult patients with moderate-to-severe atopic dermatitis.
Strong Dupixent sales drove Regeneron’s impressive second-quarter results. Label expansion of approved drugs will further boost sales. The company and partner Sanofi are also working to expand Dupixent’s label, which should diversify the company’s revenue base and reduce dependence on the lead drug, Eylea. Regeneron and Sanofi are evaluating Dupixent in a broad range of clinical development programs for diseases driven by allergic or type 2 inflammation, including asthma (under regulatory review), pediatric asthma (phase III), pediatric atopic dermatitis (phase III), adolescent atopic dermatitis (phase III), eosinophilic esophagitis (phase III), grass allergy (phase II) and peanut allergy (phase II).
The companies are also planning to evaluate Dupixent in chronic obstructive pulmonary disease. Moreover, Dupixent is also being studied in combination with REGN-3500, which targets IL-33.
The FDA had earlier approved a supplemental Biologics License Application (sBLA) for Eylea injection in patients with wet age-related macular degeneration (wet AMD). Regeneron has co-developed Eylea with the HealthCare unit of Bayer AG (BAYRY - Free Report) .
Regeneron is working to expand its portfolio. The company and partner Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) also announced positive top-line results from a phase III study on pipeline candidate, fasinumab in patients suffering from chronic pain from osteoarthritis (OA) of the knee or hip.
5 Medical Stocks to Buy Now
Zacks names 5 companies poised to ride a medical breakthrough that is targeting cures for leukemia, AIDS, muscular dystrophy, hemophilia, and other conditions.
New products in this field are already generating substantial revenue and even more wondrous treatments are in the pipeline. Early investors could realize exceptional profits.
Click here to see the 5 stocks >>