{"id":48475,"date":"2022-09-16T13:02:27","date_gmt":"2022-09-16T11:02:27","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/chmp-adopts-positive-opinion-to-extend-indication-of-veklury-remdesivir-for-the-treatment-of-pediatric-patients-with-covid-19\/"},"modified":"2022-09-16T13:02:27","modified_gmt":"2022-09-16T11:02:27","slug":"chmp-adopts-positive-opinion-to-extend-indication-of-veklury-remdesivir-for-the-treatment-of-pediatric-patients-with-covid-19","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/chmp-adopts-positive-opinion-to-extend-indication-of-veklury-remdesivir-for-the-treatment-of-pediatric-patients-with-covid-19\/","title":{"rendered":"CHMP Adopts Positive Opinion to Extend Indication of Veklury\u00ae (Remdesivir) for the Treatment of Pediatric Patients with COVID-19"},"content":{"rendered":"
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\n— If Granted by the European Commission, Veklury Will Become the First and Only Authorized Antiviral Treatment for Pediatric Patients Under 12 Years of Age in the European Union —<\/i><\/b>\n<\/p>\n

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion to extend the indication of Veklury\u00ae<\/sup> (remdesivir) for the treatment of pediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19 and pediatric patients (4 weeks of age and older and weighing at least 3 kg) with SARS-CoV-2 with pneumonia who require supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment). The European Commission (EC) will review the CHMP recommendation, and if adopted, Veklury will be the only authorized COVID-19 treatment for adolescents at high risk of progressing to severe COVID-19 and pediatric patients with COVID-19 requiring supplemental oxygen.\n<\/p>\n

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\n\u201cAs the pandemic persists, there remains a critical need for proven and effective antiviral therapies like Veklury that can treat some of the most vulnerable in our society,\u201d said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. \u201cWe are proud of today\u2019s CHMP opinion that represents a positive step toward bridging the treatment gap for children and helping them recover from COVID-19 more quickly.\u201d\n<\/p>\n

\nThis positive opinion was based on results from the ongoing CARAVAN Phase 2\/3 study, which demonstrated Veklury was generally well-tolerated among pediatric patients hospitalized with COVID-19, with a high proportion of participants showing clinical improvement and recovery, as well as data from trials in adults. Of the 53 pediatric patients enrolled in the CARAVAN study, no new safety signals were apparent for patients treated with Veklury. Overall, 75% and 85% showed clinical improvement (\u22652 point increase on an ordinal scale) at Day 10 and last assessment, respectively, while 60% and 83% were discharged by Day 10 and Day 30, respectively. In the study, 38 patients (72%) experienced adverse events (AEs), with 11 patients (21%) experiencing serious adverse events (SAEs) that were determined not to be study-drug related, including three participant deaths, which were consistent with the patients\u2019 underlying medical conditions prior to study entry or with COVID-19 during hospitalization.\n<\/p>\n

\n\u201cAs the COVID-19 pandemic evolves, it\u2019s important to have effective treatments with well-established safety profiles, including for the vulnerable groups like children to help them recover faster from COVID-19,\u201d said Pablo Rojo, MD, PhD, Pediatric Infectious Diseases Specialist of Hospital 12 de Octubre, Madrid, Spain and Associate Professor of Complutense University, Madrid, Spain. \u201cTherefore, the medical community welcomes this CHMP positive opinion for Veklury in pediatric patients and looks forward to the EC decision.\u201d\n<\/p>\n

\nIn the European Economic Area (EEA), Veklury is the only antiviral indicated for both the treatment of COVID-19 in adult patients who do not require supplemental oxygen and are at increased risk of developing severe COVID-19, as well as 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).\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. Veklury is a foundation 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 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 directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. Based on in vitro<\/i> analyses, Veklury retains antiviral activity against Omicron subvariants BA.2.12.2, BA.4 and BA.5, which are currently the most common circulating variants. Data continue to confirm that Veklury retains antiviral activity against all Omicron subvariants analyzed to date. Gilead continuously evaluates the activity of Veklury against new SARS-CoV-2 variants of concern as they emerge around the world.\n<\/p>\n

\nVeklury is approved in more than 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 (\u226528 days old and weighing \u22653 kg) with positive results of SARS-CoV-2 viral testing, who are:\n<\/p>\n