Dupixent Receives New Indication
June 26, 2019 – The U.S. FDA has approved a new indication for Dupixent® (dupilumab), manufactured by Regeneron Pharmaceuticals. The drug is now approved as an add-on maintenance treatment for adults who have chronic rhinosinusitis with nasal polyps (CRSwNP) that is not adequately controlled.
CRSwNP, a chronic disease of the upper airway that obstructs the sinuses and nasal passages, often occurs alongside other medical conditions. Up to 56% of patients who have CRSwNP have asthma, and 10% of CRSwNP patients have aspirin exacerbated respiratory disease (AERD). Patients who have both CRSwNP and asthma tend to have severe asthma that is difficult to treat. Current standards of treatment for CRSwNP include steroids, nasal saline rinses, and surgical polyp removal.
In clinical studies, patients treated with Dupixent experienced up to a 57% improvement in severity of nasal congestion and obstruction compared to a 19% improvement in patients who received a placebo. Patients who received Dupixent also saw up to a 33% reduction in their nasal polyps score compared to up to a 7% increase with placebo. Treatment with Dupixent reduced the proportion of patients who required systemic corticosteroids by 74% compared to placebo, and lowered the proportion of patients who required sinonasal surgery by 83% compared to placebo. For the 59% of patients who also had asthma, improvements in lung function were similar to patients in the Dupixent asthma program.
Recommended dosing under the new indication is 300mg administered via subcutaneous (SC) injection once a week. Patients or a caregiver can administer Dupixent at home if properly trained in administration technique by a healthcare provider.
First FDA approved in 2017, Dupixent is also indicated to treat certain patients who have moderate-to-severe atopic dermatitis, and certain patients who have moderate-to-severe asthma.