U.K.-based biotech firm Shire reported Friday topline results from its phase 3 trial of Vonvendi that met its primary endpoint of effectively controlling bleeding and blood loss during surgical procedures.
The trial is evaluating the drug for the treatment of bleeding in elective surgical settings for adults with severe von Willebrand disease, a common inherited bleeding disorder. Results from the study indicated that the drug effectively controlled bleeding and blood loss during operations.
The results will form the basis of a supplemental new drug application to the U.S. Food and Drug Administration, and for similar approvals in Europe in 2017 and in other markets. ADRs were 2.5% higher in recent morning trade.
By Stephen Holmes