PARIS (dpa-AFX) - Sanofi (SNY), Friday announced that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has recommended the approval of Wayrilz for the treatment of immune thrombocytopenia in adults.
The recommendation is based on the pivotal LUNA 3 phase 3 study, where Wayrilz met both the primary and secondary endpoints, making LUNA 3 the first phase 3 study to show a positive impact on sustained platelet counts, bleeding, and other ITP symptoms.
The company expects a final decision from the agency in the coming months.
In the pre-market hours, SNY is trading at $50.07, up 0.10 percent on the Nasdaq.
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