Gilead Sciences, Inc. (Nasdaq: GILD) announced exciting news today regarding its antiviral treatment Veklury (remdesivir). It has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its use in treating COVID-19 patients with severe renal impairment, including those on dialysis.
The European Commission (EC) will now review the recommendation and, if adopted, Veklury will become the first authorized antiviral COVID-19 treatment available for patients across all stages of renal disease. This is incredibly promising news for the medical community in the fight against COVID-19.
In Europe, approximately 75 million people are faced with the debilitating effects of Chronic Kidney Disease (CKD). Those suffering from advanced stages of CKD or End Stage Kidney Disease (ESKD) are in an especially fragile situation during the COVID-19 pandemic, greatly increasing their chances of severe illness and even death, with mortality rates reaching a high of twenty-one to twenty-five percent. Though currently limited, treatments that are both safe and effective are being explored to address this worrying issue.
Today, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Veklury® (remdesivir) for the treatment of adult and pediatric patients aged 12 years or older with COVID-19 who have severe disease or are at risk of progressing to severe disease. This announcement brings renewed hope to individuals, particularly those with renal impairment, who are particularly vulnerable to the effects of the virus.
At Gilead Sciences, we are committed to serving the needs of those who are most in need. We are delighted by the CHMP’s opinion and will remain committed to developing treatment options for these vulnerable populations and addressing unmet needs in the fight against COVID-19.
The use of Veklury in hospitalized populations with COVID-19 has been backed by a variety of clinical studies, real-world evidence and meta-analyses, and recently its use has been extended to patients with severe renal impairment (<30mL/min).
The approval was due to the successful results reported from a Phase 1 Pharmacokinetic study (GS-US-540-9015) and the Phase 3 REDPINE trial, where no new safety signals were identified. With this positive opinion, those suffering from severe renal impairment can now access the potential benefits of Veklury for their condition.
The European Medicine Agency’s positive opinion on Veklury for people with severe renal impairment has been a welcomed boost to those in the healthcare community, with Prof. Dr. Tobias Welte, Professor of Pulmonary Medicine and Director of the Department of Pulmonary and Infectious Diseases at Hannover University School of Medicine applauding the potential gain in access to treatment for more people.
“The safety profile of Veklury in this population is an encouraging sign and expanding its use will help provide more people with the treatments they need for COVID-19.”
Veklury stands out in the European Economic Area (EEA) as the only antiviral indicated to treat both adult and adolescent patients at increased risk of developing severe COVID-19, who don’t require supplemental oxygen, and adults, adolescents and pediatric patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation). With Veklury, the battle against COVID-19 can be fought effectively and efficiently from every angle!
About GS-US-540-5912 (REDPINE)
Gilead recently wrapped up their REDPINE trial, a double-blind, placebo-controlled study testing the efficacy and safety of the drug Veklury for hospitalized adult participants with COVID-19 and renal impairment. Unlike initial plans, the trial had to close prematurely, yet did not report any new safety issues.
A total of 163 patients were assigned to Veklury treatment while 80 were assigned to the placebo, and from among them, 60 cases of acute kidney injury, 44 cases of CKD, and 59 cases of ESKD requiring hemodialysis were observed. As a result, no adverse reactions to Veklury were identified.
The pharmacokinetic (PK) data from the REDPINE study, along with a single-dose Phase 1 open-label, parallel-group study (GS-US-540-9015) indicated that patients with severely reduced kidney function had no measurable new safety signals with higher metabolite levels.
As a result, no dose adjustment of Veklury is necessary for patients with renal impairment, including those on dialysis. Allowing for continued access to this medication even in cases of kidney impairment helps open doors to support those in need.
About Gilead’s COVID-19 Development Program
Veklury (remdesivir) is a game-changing nucleotide analog developed by Gilead Sciences. In clinical trials, it has been proven to be the antiviral standard of care for hospitalized patients with COVID-19, while also helping to reduce disease progression in high-risk, non-hospitalized patients.
Fully tested in diverse populations, it has a well-established safety record and limited drug interactions. A powerful inhibitor of SARS-CoV-2 viral replication, Veklury has retained its action against the Omicron subvariants, such as BQ.1.1 and XBB, enabling many patients to recover faster with improved health outcomes.
Veklury, the revolutionary life-saving drug, has now been approved for use in over 50 countries around the globe. Its availability has enabled more than 13 million people, including 8 million from middle and low-income nations, to gain access to the medication. Thanks to Gilead’s voluntary licensing program, it is now possible for many to benefit from Veklury and generic remdesivir.
Gilead is actively developing a promising new oral treatment option for COVID-19: obildesivir. This direct-acting nucleoside inhibitor acts by inhibiting the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp) needed for virus replication, in the same way as its intravenous sister-treatment Veklury. Obeldesivir could prove to be a welcome breakthrough in treating COVID-19, offering a more convenient and easily accessible form of antiviral treatment.