{"id":48465,"date":"2022-09-16T01:01:55","date_gmt":"2022-09-15T23:01:55","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/who-expands-recommendation-for-veklury-remdesivir-to-patients-with-severe-disease-in-latest-update-to-covid-19-guideline\/"},"modified":"2022-09-16T01:01:55","modified_gmt":"2022-09-15T23:01:55","slug":"who-expands-recommendation-for-veklury-remdesivir-to-patients-with-severe-disease-in-latest-update-to-covid-19-guideline","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/who-expands-recommendation-for-veklury-remdesivir-to-patients-with-severe-disease-in-latest-update-to-covid-19-guideline\/","title":{"rendered":"WHO Expands Recommendation for Veklury\u00ae (Remdesivir) to Patients With Severe Disease in Latest Update to COVID-19 Guideline"},"content":{"rendered":"
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\n— 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 —<\/i><\/b>\n<\/p>\n

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced updates to the World Health Organization\u2019s (WHO) Therapeutics and COVID-19: living guideline<\/a>, which now conditionally recommends Veklury\u00ae<\/sup> (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.\n<\/p>\n

<\/a><\/p>\n

\nThe WHO conditional recommendation for Veklury\u2019s 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\u20130.93). 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\u20130.99). 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\u20130.64). Veklury did not demonstrate a mortality benefit in the overall population or other baseline oxygen subgroups in either ACTT-1 or SOLIDARITY.\n<\/p>\n

\n\u201cWhen 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,\u201d said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. \u201cThe 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\u2019s the only antiviral treatment recommended by the WHO for both patients at high risk of progression not requiring oxygen and those requiring supplemental oxygen.\u201d\n<\/p>\n

\nIn 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.\n<\/p>\n

\n\u201cThe WHO\u2019s 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,\u201d said Dr. Elizabeth Sapey, BSc, MBBS, PhD, FRCP, Professor of Acute and Respiratory Medicine at the Institute of Inflammation and Ageing, University of Birmingham. \u201cWith this new recommendation, the WHO guideline now better reflects the full body of evidence supporting remdesivir\u2019s role in COVID-19 treatment and aligns more closely with recommendations in most major guidelines and protocols.\u201d\n<\/p>\n

\nAbout Veklury<\/span><\/b>\n<\/p>\n

\nVeklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company\u2019s 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.\n<\/p>\n

\nVeklury 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.\n<\/p>\n

\nVeklury directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. Due to Veklury\u2019s mechanism of action, it has a high barrier to resistance. In vitro<\/i> 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.\n<\/p>\n

\nVeklury 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\u2019s voluntary licensing program. These licenses currently remain royalty-free, reflecting Gilead\u2019s existing commitment to enabling broad patient access to remdesivir.\n<\/p>\n

\nU.S. Indication for Veklury<\/span><\/b>\n<\/p>\n

\nVeklury\u00ae<\/sup> (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:\n<\/p>\n