Gilead Halts Phase 3 Study of Veklury (Remdesivir) IV in High-Risk Non-Hospitalized COVID-19 Patients Amid Evolving Pandemic Landscape

April 13, 2021 News /BioonBIOON/ -- Currently, the COVID-19 epidemic overseas continues to spread rapidly. According to Baidu's "Real-time Epidemic Situation of Novel Coronavirus Pneumonia"Big DataReport》, as of 17:00 on April 13, 2021, the global cumulative confirmed cases exceeded 130 million (137.3 million), with more than 2.96 million deaths.

Recently, Gilead Sciences issued a statement announcing its decision to discontinue the Phase 3 study of Veklury (remdesivir) intravenous (IV) formulation in high-risk non-hospitalized patients with COVID-19. Given the evolving landscape of COVID-19 and the challenges associated with patient enrollment, Gilead no longer believes that developing a multi-day IV infusion therapy requiring administration in healthcare settings addresses the unmet needs among non-hospitalized patients. This decision to halt the study was not based on efficacy or safety considerations. Patients already enrolled in the study will continue to be followed up, and the study will remain blinded.

Although COVID-19 continues to affect many patients and their loved ones, unmet medical needs have continued to evolve throughout the pandemic. The primary unmet need for non-hospitalized patients with COVID-19 is effective and convenient treatment options that can be easily administered at home.

Gilead remains committed to developing treatment regimens for non-hospitalized patients with COVID-19 to address this need. The company is continuing to develop an inhaled formulation of remdesivir and novel oral antiviral agents, with the aim of providing patients with effective, well-tolerated, and more convenient treatment options. Gilead expects to announce results from ongoing proof-of-concept studies in its inhaled remdesivir development program later this year.

Veklury is an antiviral medication developed by Gilead Sciences, Inc. that inhibits the replication of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19). In the United States, Veklury has been approved for the treatment of pediatric and adult patients aged 12 years and older, weighing at least 40 kg, who require hospitalization for COVID-19. The use of Veklury is restricted to hospitals or healthcare settings capable of providing acute care comparable to that provided in a hospital setting for inpatients.

Veklury (remdesivir) remains the standard of care for hospitalized adult patients with COVID-19. In the United States, more than half of hospitalized COVID-19 patients have received treatment with Veklury. Gilead Sciences continues to investigate the efficacy and safety of Veklury in hospitalized patient populations with ongoing unmet medical needs, such as those with renal impairment, pediatric patients, and pregnant women, and provides support through several externally sponsored trials.

According to the annual report released in February this year, Veklury’s sales revenue reached $2.811 billion in 2020, with as much as $1.9 billion generated in the fourth quarter alone. However, as the landscape of the COVID-19 pandemic evolves, it remains uncertain how long Veklury’s success will endure.

In January this year, the pharmaceutical market research firm Evaluate Vantage released a report pointing out that fromEli LillyRoche/Regeneron’s two antibody cocktail therapies, which offer both treatment and prevention, are expected to generate substantial sales in 2021. However, long-term demand for all these products remains highly uncertain. Current forecasts suggest that demand for the aforementioned three products will gradually decline as vaccines bring the COVID-19 pandemic under control and more effective treatments become available. (Bioon.com)

Original Source: Gilead Sciences Statement on Phase 3 Veklury® (Remdesivir) Intravenous Study in High-Risk Non-Hospitalized Patients with COVID-19