Coronavirus treatment remdesivir granted conditional approval in Singapore
{{#rendered}} {{/rendered}}Singapore’s Health Sciences Authority [HSA] on Wednesday granted conditional approval for Gilead Sciences Singapore’s experimental drug Veklury (remdesivir) to treat COVID-19 infections, according to an official statement.
Remdesivir, an antiviral medication, did not prove successful in treating Ebola patients but improved coronavirus patients’ recovery time by 31 percent in a trial led by the National Institute of Allergy and Infectious Disease. In the U.S. study, patients who qualified for the drug had to be on mechanical ventilation or supplemental oxygen.
The approval will allow infectious disease specialists to administer the drug to adult COVID-19 patients who have oxygen saturation less than 94 percent, or require supplemental oxygen or breathing support, like from a mechanical ventilator.
{{#rendered}} {{/rendered}}CLICK HERE FOR FULL CORONAVIRUS COVERAGE
The HSA consulted with its Medicines Advisory Committee to grant the conditional approval. To further optimize use of the drug, the HSA is working with the Ministry of Health and other experts to further specify which patients would most likely benefit from the medicine.
The government agency said although data on remdesivir’s safety and efficacy is “very limited” at this point in time, the HSA expedited a review of the drug given the ongoing coronavirus pandemic.
{{#rendered}} {{/rendered}}As part of the conditional approval, the agency said Gilead is required to gather relevant safety data and monitor the drug use. HSA will also require data from ongoing clinical studies to ensure continued safety and efficacy.
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The HSA has reportedly been working since March to facilitate early access of remdesivir to COVID-19 patients in Singapore through expedited evaluation and approval of its use in clinical trials.
{{#rendered}} {{/rendered}}Singapore’s approval of conditional use follows similar steps taken by countries like the U.S., in which the Food and Drug Administration granted emergency authorization of remdesivir on May 1; Japan, where the drug was granted emergency approval for use on May 7; India, on June 1; and the U.K., under the Early Access to Medicines Scheme.
Fox News' Alexandria Hein contributed to this report.