EU approves variation for Veklury in COVID-19 patients.
This decision follows the positive recommendation of the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), to expand the indication for Veklury on December 16.
The EC’s decision is supported by results from a Phase III randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. In an analysis of 562 participants randomly assigned in a 1:1 ratio to receive Veklury or placebo, Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) p=0.008.
In the study, no deaths were observed in either arm by Day 28. The safety profile was similar between Veklury and placebo across the variety of outpatient settings in this trial, with the most common treatment emergent adverse events (at least 5%) in patients taking Veklury being nausea and headache. These data have also been shared with other regulatory agencies around the world and submitted for scientific peer-reviewed publication.
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