Veklury (Remdesivir) Becomes First Treatment Approved for COVID-19 in Europe as Global Cases Surpass 11 Million

July 03, 2020 /BioonBIOON/ -- Currently, the COVID-19 pandemic continues to spread rapidly worldwide. According to Baidu's "Real-time Epidemic Situation of Novel Coronavirus Pneumonia"Big DataReport, as of 01:00 on July 4, 2020, the global cumulative confirmed cases exceeded 11.05 million, and deaths exceeded 525,000.

Remdesivir, an antiviral drug from Gilead Sciences, is a highly watched potential drug for COVID-19. In early May this year, the drug was approved by the U.S.FDAEmergency Use Authorization (EUA) was granted for the treatment of hospitalized patients with severe COVID-19. Also in early May, remdesivir (brand name: Veklury®) received the world’s first regulatory approval in Japan.

Recently, remdesivir has seen positive developments in its regulatory status within the European Union. The European Commission (EC) has granted Veklury conditional marketing authorization for the treatment of novel coronavirus (SARS-CoV-2) infection, which can cause coronavirus disease 2019 (COVID-19).

Notably, Veklury is the first treatment for COVID-19 approved in the European Union. The granting of this conditional marketing authorization was based on a rolling review of supporting data that began in April 2020, taking into account the public health benefits in the context of the COVID-19 pandemic. Under this authorization, Veklury is indicated for the treatment of adult and adolescent patients (aged ≥12 years and weighing ≥40 kg) with COVID-19 who have pneumonia and require supplemental oxygen.

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Merdad Parsey, M.D., Global Chief Medical Officer of Gilead Sciences, stated: “We appreciate the European Medicines Agency’s (EMA) rapid review of remdesivir amid this unprecedented pandemic. This conditional marketing authorization represents an important step forward as we collectively work to address the treatment needs of patients across Europe.”

Veklury has been studied in hospitalized COVID-19 patients, covering a range of disease severities. The conditional marketing authorization for Veklury was supported by the global Phase III trial of remdesivir conducted by the National Institute of Allergy and Infectious Diseases (NIAID).Clinical Trialsupport. In Europe, the initial validity period of a conditional marketing authorization is one year, but the term can be extended or converted into an unconditional marketing authorization upon submission and assessment of additional confirmatory data.

Currently OngoingClinical TrialOngoing evaluations of the safety and efficacy of remdesivir are being conducted, including studies on its combination with anti-inflammatory agents and investigations in special populations, such as pediatric patients. Furthermore, new formulations of remdesivir are currently under investigation, which may facilitate its use during the early stages of the disease.

Veklury (remdesivir) is a nucleotide analog that demonstrates broad-spectrum antiviral activity against various emerging pathogens in vitro and in animal models. Multiple global Phase III clinical trials are currently underwayClinical TrialThe safety and efficacy of remdesivir for the treatment of COVID-19 are currently under evaluation. In light of the current public health emergency and based on existing clinical data, remdesivir has been approved in Japan, Taiwan (China), India, Singapore, the United Arab Emirates, and the European Union for the treatment of patients with severe COVID-19. Outside these regions, remdesivir remains an unapproved investigational drug.

In the United States, remdesivir has been granted Emergency Use Authorization (EUA) for the treatment of patients with suspected or laboratory-confirmed SARS-CoV-2 infection and severe COVID-19 disease. Severe disease is defined as: oxygen saturation (SpO2) ≤94% on room air, or the need for supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Remdesivir must be administered via intravenous injection and is authorized for use in hospitalized adult and pediatric patients who can receive clinical intravenous therapy. (Bioon.com)

Original Source:European Commission Grants Conditional Marketing Authorization for Gilead’s Veklury® (remdesivir) for the Treatment of COVID-19