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Dupilumab is a monoclonal antibody that acts to inhibit part of the inflammatory pathway. [9] Dupilumab is the first treatment for prurigo nodularis approved by the FDA. [10] Prurigo nodularis is a rare skin disease that causes hard, itchy lumps (nodules) to form on the skin. [10]
This approval expands the initial June 2019 FDA approval in CRSwNP for patients aged 18 years and older. The FDA evaluated Dupixent for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.
Safety results in both trials were generally consistent with the known safety profile of Dupixent in its approved indications. The most common side effects across indications include injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes and eosinophilia.
The approval is based on the two-part (Part A and B) EoE KIDS Phase 3 trial in children aged 1 to 11 years, which established a bridge showing the response to Dupixent in children with EoE is similar to that of the approved adult and adolescent populations. In Part A, children who received a higher dose of Dupixent (n=37) based on a weight ...
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
In the U.S., Dupixent continued its leadership in new-to-brand prescriptions across all indications, in line with the first nine months of the year. U.S. sales growth in the quarter reflected ...
A memo sent to leadership at federal health agencies noted the communication hiatus will extend through Feb. 1, a CDC official told some staffers in a call on Thursday, according to an audio ...