New EC approval for Dupixent in CSU
The European Commission has approved Dupixent (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in adult and adolescent patients with inadequate response to histamine-1 antihistamines (H1AH) and who are naive to anti- immunoglobulin-E (IgE) therapy for CSU.
Eligible patients can use Dupixent, marketed by French pharma major Sanofi (Euronext: SAN) under license from Regeneron (Nasdaq: REGN), as a first-line targeted treatment option approved in the European Union in over a decade.
Beyond the European Union, Dupixent is also approved for CSU in certain adults and adolescents in several countries including the USA and Japan. Dupixent sales of the third quarter of this year were 4.2 billion euros ($4.4 billion), +26%.
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