PARIS (dpa-AFX) - Sanofi SA (SNY) on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion on its marketing authorisation application for Rezurock, intended for the third-line treatment of adults and pediatric patients with chronic graft-versus-host disease (cGVHD).
cGVHD is a long-term complication that can occur after an allogeneic stem cell or bone marrow transplant, where the transplanted donor immune cells attack the patient's own tissues.
Rezurock is currently approved in 20 countries, including the US, UK and Canada for the treatment of patients 12 years and older with cGVHD after failure of at least two prior lines of systemic therapy. In China, it is approved for use after failure of one prior line of systemic therapy.
Sanofi shares had closed at $50.02, up 2.17%, on Thursday.
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