FDA approves Gilead’s remdesivir for hospitalised COVID-19 patients
pharmafile | October 23, 2020 | News story | Medical Communications, Sales and Marketing | COVID-19, FDA, Gilead, remdesivir
The FDA has approved Gilead’s antiviral therapy Veklury (remdesivir) for the treatment of hospitalised COVID-19 patients, making it the first and only therapy to receive full marketing authorisation to treat the virus in the US.
The approval concerns patients at least 12 years old and weighing at least 40kg, and the drug is only to be administered in a hospital or healthcare setting
The US regulator based its decision on three Phase 3 studies, including a double-blind placebo-controlled trial conducted by the National Institute of Allergy and Infectious Diseases, which supported the clinical benefit of Veklury in the treatment of this indication.
The supporting data showed that Gilead’s therapy “significantly improved” recovery times by five days compared to placebo in the overall study population and by seven days in patients requiring oxygen. Veklury also reduced progression of the disease in patients requiring oxygen, reducing the need for ventilation or extracorporeal membrane oxygenation.
“The approval of Veklury marks an important milestone in efforts to help address the pandemic by offering an effective treatment that helps patients recover faster and, in turn, helps preserve scarce healthcare resources,” commented Dr Barry Zingman, Professor of Medicine at the Albert Einstein College of Medicine and Montefiore Medical Center. “The availability of a rigorously tested treatment that can significantly speed recovery and offers other benefits such as lower rates of progression to mechanical ventilation, provides hospitalised patients and their families important hope and offers healthcare providers a critical tool as they care for patients in need.”
However, the FDA’s ruling is overshadowed by the recent revelation from a large-scale WHO study which found that Veklury, as well as three other promising treatments, did not present any definite benefit in COVID-19 mortality rates.
Matt Fellows
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