Sanofi and Regeneron’s Dupixent Receives the US FDA’s Approval to Treat Adolescents with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
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- The US FDA has approved Dupixent as an add-on treatment for adolescents (12-17yrs.) with inadequately controlled CRSwNP, based on pivotal SINUS-24 & SINUS-52 studies. This expands the previous approval in adults (≥18yrs.) for the same
- The studies demonstrated improved nasal congestion, polyp size & sense of smell at 24wks., reducing the need for corticosteroids or surgery. The PK & safety data from patients aged ≥12yrs. with mod. to sev. asthma & CRSwNP also formed the basis of approval
- The safety of Dupixent in adults aligned with its known profile. Common AEs (≥1%) included injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia & conjunctivitis
Ref: Regeneron | Image: Sanofi & Regeneron
Related News:- Regeneron and Sanofi Report the EC’s Approval of Dupixent to Treat Chronic Obstructive Pulmonary Disease (COPD)
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
