This decision follows the positive recommendation of the Committee for Medicinal Products for Human Use, 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 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 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.
This expanded indication in the EU adds to the previous Conditional Marketing Authorization of Veklury enabling the treatment of COVID-19 in adults and adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment).
In the United States, Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) 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 US is investigational, and the safety and efficacy for this use and dosing duration have not been approved by the US Food and Drug Administration.
Veklury is contraindicated in patients who are allergic to Veklury or any of its components; please see below for additional Important Safety Information for Veklury.
As new SARS-CoV-2 variants of concern emerge around the world, Gilead continuously evaluates the effectiveness of Veklury against viral variants.
An initial analysis of genetic information from the Omicron variant suggests that Veklury will continue to be active against this variant.
Gilead will conduct laboratory testing to confirm this analysis. To date, no major genetic changes have been identified in any of the known variants of concern that would significantly alter the viral RNA polymerase targeted by Veklury.
Veklury's antiviral activity has been tested in vitro against isolates of variants of SARS-CoV-2, including Alpha, Beta, Gamma, Delta and Epsilon.
These laboratory findings suggest that Veklury will continue to be active against the currently identified variations in the SARS-CoV-2 virus, including the Omicron variant.
Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company's antiviral research.
Veklury is the antiviral standard of care for the treatment of hospitalized patients with COVID-19.
At this time, more than half of patients hospitalized with COVID-19 in the United States are treated with Veklury.
It can help reduce disease progression across the spectrum of disease severity and enable hospitalized patients to recover faster, freeing up limited hospital resources and saving healthcare systems money.
Veklury is approved or authorized for temporary use in approximately 50 countries worldwide.
To date, Veklury and generic remdesivir have been made available to nine m patients around the world, including 6.5m people in 127 middle- and low-income countries through Gilead's voluntary licensing program.
These licenses currently remain royalty-free, reflecting Gilead's existing commitment to enabling broad patient access to remdesivir.
Veklury (remdesivir 100 mg for injection) is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.
Apotex launches Teriparatide Injection in US
Teva Pharmaceuticals secures FDA approval for generic Forteo (teriparatide injection)
Upsher-Smith Laboratories introduces Pitavastatin Tablets
Par Pharmaceutical starts shipping colchicine 0.6mg capsules
Padagis launces Brinzolamide Ophthalmic Suspension with CGT exclusivity
Novartis completes Sandoz Spin-off
Novartis completes Sandoz spin-off, focusing on innovative medicines
Sanofi and Teva collaborate on innovative IBD treatment
Hikma marks KLOXXADO two-year anniversary by surpassing 375,000 doses donated in the US
STADA seeks full approval for Kinpeygo in IgA nephropathy from UK MHRA
Azurity Pharmaceuticals completes Slayback Pharma acquisition
Sandoz secures European approval for Tyruko biosimilar in MS treatment
Senores Pharmaceuticals introduces Nicardipine Hydrochloride Capsules USP, 20mg and 30mg in US
Lupin collaborates with Mark Cuban Cost Plus Drug Company and COPD foundation
Certara Simcyp receives FDA grants for advanced pharmacokinetic modelling