AsianScientist (Jun. 16, 2020) – Singapore’s Health Science Authority has granted regulatory approval of remdesivir as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19, on a conditional basis.
Remdesivir is a nucleotide analog with broad-spectrum antiviral activity both in vitro and in animal models against multiple emerging viral pathogens.
Gilead filed for registration of remdesivir—which has been given the trade name Veklury—in Singapore on May 22 and obtained conditional approval on June 10.
Infectious diseases specialists are now permitted to administer remdesivir for the treatment of adult patients who meet the following criteria for severe COVID-19: they must have an oxygen saturation of less than or equal to 94 percent; require supplemental oxygen; or require more intensive breathing support such as extracorporeal membrane oxygenation or invasive mechanical ventilation.
The conditional approval is based on clinical data from the US National Institute of Allergy and Infectious Diseases’ global Phase III trial and Gilead’s Phase III SIMPLE trial in patients with severe manifestations of COVID-19. Singapore participated in both clinical trials and has enrolled around 100 patients. As part of the condition of the approval, data from ongoing clinical studies will be submitted to HSA to ensure continued safety and efficacy of the product.
According to a press statement, Gilead is scaling up manufacturing of remdesivir given the limited global supply of the drug. The company anticipates new supplies of the drug to start to become available in July, with supply continuing to increase through the end of 2020 and into next year.
“Gilead will work closely with the health authorities in Singapore to provide guidance on anticipated drug supply based on local incidence and severity of disease,” Mr. Daniel Li, senior director of clinical operations at Gilead Sciences, told Asian Scientist Magazine.
Singapore is among the earliest countries in Asia, besides Japan and Taiwan, to approve remdesivir as a treatment for patients with severe COVID-19. Outside of these regions, remdesivir is an investigational, unapproved drug.
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Source: Gilead; Photo: Dimitri Karastelev/Unsplash.
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