FOSTER CITY, Calif.--(BUSINESS WIRE)--May 26, 2023--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion for the use of Veklury ® (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis. The European Commission (EC) will review the CHMP recommendation and, if adopted, Veklury will become the first and only authorized antiviral COVID-19 treatment that can be used across all stages of renal disease.
In Europe, approximately 75 million people suffer from chronic kidney disease (CKD). Patients with advanced CKD or end stage kidney disease (ESKD) represent a population that is highly vulnerable to COVID-19. They are at increased risk of morbidity and mortality from COVID-19, with mortality rates as high as 21-25%, and currently have limited treatment options that are safe and effective.
“COVID-19 continues to pose a threat to the lives of vulnerable individuals, including those with renal impairment,” said Anu Osinusi, Vice President, Clinical Research for Hepatitis, Respiratory and Emerging Viruses, Gilead Sciences. “Gilead’s commitment to address the unmet needs of the most susceptible populations remains a top priority. We are encouraged by today’s CHMP opinion and will continue to invest in developing suitable treatment options for populations at risk of severe disease.”
The clinical benefit of Veklury in hospitalized populations with COVID-19 is supported by randomized controlled trials, real-world evidence and meta-analyses, but its use has previously been restricted among patients with severe renal impairment (<30mL/min) due to insufficient data. This positive opinion for use in people with severe renal impairment was based on results from a Phase 1 Pharmacokinetic study (GS-US-540-9015), as well as results from the Phase 3 REDPINE trial that evaluated the safety of Veklury in patients hospitalized for COVID-19 with severe renal impairment. No new safety signals were observed in either of the studies.
“The positive opinion from the Committee helps validate the safety profile of Veklury in people with severe renal impairment,” said Prof. Dr. Tobias Welte, Professor of Pulmonary Medicine and Director of the Department of Pulmonary and Infectious Diseases at Hannover University School of Medicine. “Expanding the use of Veklury in this population, which still has limited treatment options, will help more people gain access to treatment for COVID-19.”
In the European Economic Area (EEA), Veklury is the only antiviral indicated for both the treatment of COVID-19 in adult and adolescent patients who do not require supplemental oxygen and are at increased risk of developing severe COVID-19, as well as adults, adolescent and pediatric patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation).
About GS-US-540-5912 (REDPINE)
Gilead conducted a Phase 3, randomized, double-blind, placebo-controlled parallel-group, multicenter study (REDPINE) evaluating the efficacy and safety of Veklury in patients with severely reduced kidney function who are hospitalized with COVID-19. The trial enrolled 243 hospitalized adult participants with confirmed COVID-19 and renal impairment who were randomized in a 2:1 manner to receive Veklury (n=163) or placebo (n=80), in addition to standard of care, and were stratified by ESKD, high-flow oxygen requirement, and region (US vs. ex-US). The study closed prematurely due to feasibility issues and was underpowered to assess for efficacy because of lower-than-expected enrollment. No new safety signals were observed in the study and no additional adverse reactions to Veklury were identified in 163 hospitalized patients with confirmed COVID-19 and acute kidney injury (AKI) (n=60), CKD (eGFR <30 mL/minute) (n=44) or ESKD (eGFR <15 mL/minute) requiring hemodialysis (n=59) receiving Veklury for up to 5 days.
Pharmacokinetic data were obtained from the REDPINE study, as well as a Phase 1 open-label, parallel-group, single-dose study (GS-US-540-9015). Given the observed PK and the absence of any new safety signals associated with increased metabolite levels in patients with severely reduced kidney function, no dose adjustment of Veklury is recommended in patients with renal impairment, including those on dialysis.
About Gilead’s COVID-19 Development Program
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 and is a recommended treatment for reducing disease progression in non-hospitalized patients at high risk of disease progression. Veklury has an established safety profile and minimal known drug interactions in diverse populations. It plays an important role in reducing disease progression and mortality across a spectrum of disease severity and enabling patients to recover faster. Veklury directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. Based on in vitro analyses, Veklury retains antiviral activity against recent Omicron subvariants of concern, including BQ.1.1 and XBB.
Veklury is approved in more than 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to nearly 13 million patients around the world, including more than 8 million people in middle- and low-income countries through Gilead’s voluntary licensing program.
There remains a significant need to develop new and effective oral treatment options for people with COVID-19. Gilead is also working to advance an investigational oral antiviral, obeldesivir, for the treatment of COVID-19. Obeldesivir is a direct-acting nucleoside inhibitor of the of the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), a critical component that the virus uses to replicate. Once metabolized, obeldesivir works in the same way as Veklury to halt SARS-CoV-2 virus replication.
U.S. Indication for Veklury
Veklury ® (remdesivir 100 mg for injection) is indicated for the treatment of COVID-19 in adults and pediatric patients (≥28 days old and weighing ≥3 kg) who are:
- Hospitalized, or
- Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
For more information, please see the U.S. full Prescribing Information available at www.gilead.com.
U.S. Important Safety Information for Veklury
Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Veklury or any of its components.
Warnings and precautions
- Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of Veklury; most occurred within one hour. Monitor patients during infusion and observe for at least one hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time up to 120 minutes) can potentially prevent these reactions. If a severe infusion-related hypersensitivity reaction occurs, immediately discontinue Veklury and initiate appropriate treatment (see Contraindications).
- Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and in patients with COVID-19 who received Veklury; these elevations have also been reported as a clinical feature of COVID-19. Perform hepatic laboratory testing in all patients (see Dosage and administration). Consider discontinuing Veklury if ALT levels increase to >10x ULN. Discontinue Veklury if ALT elevation is accompanied by signs or symptoms of liver inflammation.
- Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine: Coadministration of Veklury with chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data from cell culture experiments, demonstrating potential antagonism, which may lead to a decrease in antiviral activity of Veklury.
- The most common adverse reaction (≥5% all grades) was nausea.
- The most common lab abnormalities (≥5% all grades) were increases in ALT and AST.
- Drug interaction trials of Veklury and other concomitant medications have not been conducted in humans.
Dosage and administration
- Administration should take place under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible.
- Treatment duration:
- For patients who are hospitalized, VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19.
- For patients who are hospitalized and do not require invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended up to 5 additional days, for a total treatment duration of up to 10 days.
- For patients who are hospitalized and require invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days.
- For patients who are not hospitalized, diagnosed with mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death, the recommended total treatment duration is 3 days. VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 and within 7 days of symptom onset for outpatient use.
- Testing prior to and during treatment: Perform eGFR, hepatic laboratory, and prothrombin time testing prior to initiating VEKLURY and during use as clinically appropriate.
- Renal impairment: VEKLURY is not recommended in individuals with eGFR <30 mL/min.
Pregnancy and lactation
- Pregnancy: A pregnancy registry has been established. There are insufficient human data on the use of Veklury during pregnancy. COVID-19 is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease and fetal death.
- Lactation: It is not known whether Veklury can pass into breast milk. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.
About Gilead Sciences
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. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to effectively manage the supply and distribution of Veklury; Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Veklury and obeldesivir; the possibility that Gilead may make a strategic decision to discontinue development of Veklury and obeldesivir for any indications that are currently under investigation, and as a result, Veklury and obeldesivir may never be commercialized for such indications; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that the European Commission may not approve Veklury for treatment of COVID-19 patients with severe renal impairment, including those on dialysis, without the need to test renal function or for dosing adjustments in the currently anticipated timelines or at all; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use, and the risk that physicians may not see the benefits of prescribing Veklury such indication; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
U.S. full Prescribing Information for Veklury is available atwww.gilead.com.
Veklury, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company’s website atwww.gilead.com,follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
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