Dupixent receives FDA approval as first CRSwNP treatment
WEB5 days ago · This is the first treatment available in this age group for CRSwNP, a chronic inflammatory disease of the upper airway. Approved for adults in June 2019, Dupixent’s new indication was granted priority review by the FDA. The decision was supported by results from two pivotal trials in adults, SINUS-24 and SINUS-52, which demonstrated ...
FDA Approves Dupilumab Label Expansion with Indication for CRSwNP …
WEBSep 13, 2024 · The FDA today approved the biologic dupilumab (Dupixent; Sanofi/Regeneron) as add-on maintenance therapy for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP), according to an announcement from Regeneron. The decision, following the agency's priority review of phase 3 clinical ...
Regeneron, SNY Win FDA Approval for a Broader Dupixent Label
WEB4 days ago · The latest approval expands the initial FDA approval (granted in June 2019) in CRSwNP for patients aged 18 years and older. Regeneron’s shares have rallied 31.3% year to date compared to the ...
Dupixent® (dupilumab) Approved in the U.S. as First and Only …
WEBSep 13, 2024 · CRSwNP is a chronic disease of the upper airway, driven in part by type 2 inflammation, that obstructs the sinuses and nasal passages. It can lead to breathing difficulties, nasal congestion and discharge, reduced or loss of sense of smell and taste, facial pressure, sleep disturbance, and overall reduction in quality of life.
Dupixent Approval Expanded for Peds Patients With CRSwNP
WEBSep 13, 2024 · Dupixent, an interleukin-4 receptor alpha antagonist, is supplied in single-dose prefilled syringes and prefilled pens. The recommended dosage for patients aged 12 years and older with CRSwNP is ...
Dupixent® (dupilumab) Recommended for EU Approval by the …
WEB1 day ago · Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), EoE, prurigo nodularis, chronic spontaneous urticaria and chronic obstructive pulmonary disease (COPD) in different age populations.
FDA accepts sBLA for dupilumab to treat CRSwNP in patients …
WEBMay 13, 2024 · Dupixent (dupilumab) sBLA accepted for FDA Priority Review for treatment of adolescents with chronic rhinosinusitis with nasal polyposis (CRSwNP). Regeneron PHarmaceuticals. Press release.
Sanofi US News
WEBMay 13, 2024 · Dupixent is currently approved as an add-on maintenance treatment for adults with CRSwNP whose disease is not adequately controlled. The sBLA in adolescents is supported by an extrapolation of efficacy data from two positive pivotal studies (SINUS-24 and SINUS-52) in adults with CRSwNP. These …
Dupilumab Beneficial for Severe CRSwNP and Asthma
WEBJul 31, 2024 · Dupilumab could be a promising treatment especially for patients with both severe CRSwNP and poorly controlled asthma by targeting a shared underlying pathophysiology. The T&T odor detection and recognition thresholds were improved significantly after 48 weeks of treatment (both P <.001).
Treatment options for chronic rhinosinusitis with nasal polyps
WEBNov 1, 2021 · Background: The management of chronic rhinosinusitis with nasal polyps (CRSwNP) is evolving, with an emphasis on treating the underlying type 2 inflammation. Objective: The objective was to summarize the updated evidence-based medical and surgical treatment recommendations for CRSwNP, …