Roche (ROP SW) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of Gazyva/Gazyvaro
ORIGINAL · NewsquawkRoche (ROP SW) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of Gazyva/GazyvaroRead originalHide original
The positive recommendation is based on results from the phase III ALLEGORY study, which demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint. The primary endpoint is the percentage of people who achieve SLE Responder Index four at week 52.
Roche announced that the EMA committee recommended approval of Gazyva/Gazyvaro.
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The positive recommendation is based on results from the phase III ALLEGORY study, which demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint. The primary endpoint is the percentage of people who achieve SLE Responder Index four at week 52.
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