-- Veklury is Now Recommended by the WHO for Use in Both Non-Severe COVID-19 Patients at the Highest Risk of Hospitalization and Patients with Severe COVID-19 --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced updates to the World Health Organization’s (WHO) Therapeutics and COVID-19: living guideline, which now conditionally recommends Veklury® (remdesivir) for the treatment of patients with severe COVID-19 and continues to conditionally recommend Veklury in those with non-severe COVID-19 at the highest risk of hospitalization.
The WHO conditional recommendation for Veklury’s use in the treatment of patients with severe COVID-19 is mainly driven by the final results of the WHO-sponsored SOLIDARITY study, which showed a statistically significant 17% lower relative risk of death or progression to needing ventilation in patients requiring supplemental oxygen at baseline, compared to standard of care (RR: 0.83; 95% CI: 0.75–0.93). Additionally, SOLIDARITY showed a statistically significant 13% lower relative risk of mortality with Veklury treatment for those patients hospitalized on supplemental oxygen and not requiring mechanical ventilation, compared with standard of care (RR: 0.87; 95% CI: 0.76–0.99). In the study, Veklury had no significant effect on patients with COVID-19 who were already being ventilated. These findings complement results from the National Institute of Allergy and Infectious Diseases' double-blind placebo-controlled ACTT-1 trial, in which a mortality reduction was seen in Veklury-treated patients on low flow oxygen at baseline, as compared to placebo, in a post-hoc subgroup analysis (HR: 0.30; 95% CI: 0.14–0.64). Veklury did not demonstrate a mortality benefit in the overall population or other baseline oxygen subgroups in either ACTT-1 or SOLIDARITY.
“When the full results of SOLIDARITY were published in May 2022, it showed that Veklury reduced mortality and progression to ventilation for those patients who were oxygenated and not ventilated. These findings are consistent with other studies, such as ACTT-1,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “The WHO guideline plays an important part in informing COVID-19 treatment in many parts of the world. We are pleased this guideline update reflects the critical role that Veklury plays in helping to reduce disease progression or death from COVID-19. Veklury and generic remdesivir have been made available to more than 11 million patients around the world, and it’s the only antiviral treatment recommended by the WHO for both patients at high risk of progression not requiring oxygen and those requiring supplemental oxygen.”
In the WHO guideline, patients with severe COVID-19 are defined as those with oxygen saturation less than 90% on room air, signs of pneumonia and/or signs of severe respiratory distress; it does not include critically ill patients on mechanical ventilation. Numerous credible national and international organizations, including the U.S. National Institutes of Health (NIH) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID), recommend Veklury for the treatment of COVID-19 across a broad spectrum of disease severity, including both non-severe COVID-19 patients at high risk of hospitalization and patients with severe COVID-19.
“The WHO’s latest COVID-19 guideline update will help further expand access for remdesivir to those with more significant disease who are in need of effective treatment options,” said Dr. Elizabeth Sapey, BSc, MBBS, PhD, FRCP, Professor of Acute and Respiratory Medicine at the Institute of Inflammation and Ageing, University of Birmingham. “With this new recommendation, the WHO guideline now better reflects the full body of evidence supporting remdesivir’s role in COVID-19 treatment and aligns more closely with recommendations in most major guidelines and protocols.”
Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company’s antiviral research. Remdesivir has an established safety profile and minimal drug interactions in diverse populations. 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. 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 a spectrum of disease severity and enable patients to recover faster, freeing up limited hospital resources and saving healthcare systems money.
Veklury was approved by the FDA in October 2020, 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. In January 2022, the FDA approved a sNDA to expand the indication to non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or death. This allows for Veklury to be administered in qualified outpatient settings that can administer daily intravenous (IV) infusions over three consecutive days. In April 2022, Veklury was approved by the FDA for the treatment of pediatric patients over 28 days old and weighing at least 3 kg who are hospitalized or not hospitalized and at high risk of progression to severe COVID-19, including hospitalization or death. 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.
Veklury directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. Due to Veklury’s mechanism of action, it has a high barrier to resistance. In vitro laboratory testing in multiple independent studies show that Veklury continues to demonstrate durable activity against SARS-CoV2 as it evolves, including the Delta variant and Omicron variants BA.4 and BA.5. As new SARS-CoV-2 variants of concern emerge around the world, Gilead continuously evaluates the effectiveness of Veklury against viral variants.
Veklury is approved or authorized for temporary use in approximately 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to more than 11 million patients around the world, including more than 7 million 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.
U.S. Indication for Veklury
Veklury® (remdesivir 100 mg for injection) is indicated for the treatment of COVID-19 in adults and pediatric patients (at least 28 days old and weighing at least 3 kg) with positive results of SARS-CoV-2 viral testing, 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
- Dosage: For adults and pediatric patients weighing ≥40 kg: 200 mg on Day 1, followed by once-daily maintenance doses of 100 mg from Day 2 administered only via intravenous infusion. For pediatric patients ≥28 days and weighing ≥3 kg: 5 mg/kg on Day 1, followed by once-daily maintenance doses of 2.5 mg/kg from Day 2, administered only via intravenous infusion.
- For hospitalized patients requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days. Veklury should be initiated as soon as possible after diagnosis of symptomatic COVID-19.
- For hospitalized patients not requiring 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 for up to 5 additional days for a total treatment duration of up to 10 days.
- For non-hospitalized patients diagnosed with mild-to-moderate COVID-19 who 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.
- 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.
Dose preparation and administration:
- There are two different formulations of Veklury: Veklury for injection (supplied as 100 mg lyophilized powder in vial) and Veklury injection (supplied as 100 mg/20 mL [5 mg/mL] solution in vial). The only approved dosage form for pediatric patients weighing 3 kg to ≤40 kg is the lyophilized powder formulation; See full Prescribing Information.
- Administration should take place only under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible.
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 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; the risk that physicians may not see the benefits of prescribing Veklury for the treatment of severely ill patients with COVID-19; 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 June 30, 2022, 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 at www.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 at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Jacquie Ross, Investors
Nicole Rodriguez, Media