Regeneron Pharmaceuticals Inc announces EC marketing approval for Dupixent (dupilumab) for moderate-to-severe atopic dermatitis.
Global Banking News-August 6, 2019-Regeneron Pharmaceuticals Inc announces EC marketing approval for Dupixent (dupilumab) for moderate-to-severe atopic dermatitis
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Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi Tuesday jointly announced the extended marketing approval from European Commission (EC) for Dupixent (dupilumab) in the EU to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.
In addition, Dupixent comes in 200 mg and 300 mg doses in pre-filled syringe for adolescents with atopic dermatitis. It is intended for injection under the skin and is given every other week following an initial dose (400 mg and 600 mg, respectively). It can be given in a clinic or at home by self-administration, revealed the company.
According to the company, Dupixent is now the first biologic medicine approved in the EU to treat these patients with moderate-to-severe atopic dermatitis, the most common form of eczema and characterized by rashes with intense, persistent itching, skin lesions and skin dryness, cracking, redness, crusting and oozing.
The company added Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. The IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, as well as asthma and chronic rhinosinusitis with nasal polyposis.
This EC approval is based on clinical data from the company's LIBERTY AD programme, including a pivotal Phase 3 trial and an open-label extension trial evaluating the efficacy and safety of Dupixent in adolescents with uncontrolled moderate-to-severe atopic dermatitis.
Concurrently, the key data points from the pivotal trials of Dupixent at 16 weeks includes 75% improvement in disease extent and severity, 75% or greater skin improvement as measured by the Eczema Area and Severity Index (EASI-75), the co-primary endpoint, more than ten times clear or almost clear skin as well as 24% achieved clear or almost clear skin as measured by an Investigator's Global Assessment (IGA) score of 0 or 1, the co-primary endpoint, concluded the company.
((Distributed via M2 Communications - http://www.m2.com))
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|Publication:||Global Banking News (GBN)|
|Date:||Aug 6, 2019|
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