Gilead Sciences: EC Approves Variation To Conditional Marketing Authorization For Veklury
Gilead Sciences, Inc. (GILD) announced Tuesday that the European Commission has approved a variation to the Conditional Marketing Authorization for Veklury (remdesivir) to include adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19.
The decision follows the positive recommendation of the Committee for Medicinal Products for Human Use or CHMP, the scientific committee of the European Medicines Agency, to expand the indication for Veklury on December 16.
The EC’s decision is supported by results from a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury for intravenous or IV use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression.
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 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.
The company said the expanded indication in the EU adds to the previous Conditional Marketing Authorization of Veklury enabling the treatment of COVID-19 in adults and adolescents with pneumonia requiring supplemental oxygen.
In the United States, Veklury is indicated for adults and pediatric patients for the treatment of COVID-19 requiring hospitalization.
The use of Veklury for the treatment of non-hospitalized patients with three days of dosing in the U.S. is investigational, and the safety and efficacy for this use and dosing duration have not been approved by the U.S. Food and Drug Administration.
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