Regeneron Pharmaceuticals Inc. and its French pharmaceutical partner Sanofi have received approval to market their antibody drug dupilumab in Europe for adults afflicted with the chronic rashes, debilitating itching and other symptoms of moderate to severe atopic dermatitis despite treatment with commonly prescribed skin creams and ointments.
Marketed under the brand name Dupixent, the drug in March was approved for the U.S. market by the Food and Drug Administration. Regeneron, headquartered on the Landmark at Eastview life sciences campus in Greenburgh and Mount Pleasant, and Sanofi on Thursday announced the European Commission”™s authorization to market Dupixent in the European Union.
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Made by combining a human antibody with part of an antibody cloned from the cell of a genetically modified mouse, dupilumab targets two key proteins considered to be major drivers of the underlying inflammation in atopic dermatitis and certain other allergic diseases, according to Regeneron and Sanofi. The drug comes in a pre-filled syringe and, after an initial loading dose, can be injected under the skin every other week by the patient.
Dr. George D. Yancopoulos, president and chief scientific officer of Regeneron, said Dupixent “represents the culmination of decades of our scientific research into the biology of allergic diseases such as moderate-to-severe atopic dermatitis.” He said the company continues “to evaluate the potential of dupilumab in the treatment of atopic dermatitis in children and adolescents as well as other allergic inflammatory diseases” driven by those identified proteins.
Dr. Elias Zerhouni, president of global research and development at Sanofi, said the European Commission”™s approval “demonstrates our approach of bringing innovative new therapies to those living with the highest unmet medical need and represents an important milestone for people living with moderate-to-severe atopic dermatitis in Europe.”
