SINGAPORE: Antiviral drug remdesivir has been granted conditional approval to be administered to COVID-19 patients in Singapore who are severely ill, the Health Sciences Authority (HSA) said on Wednesday (Jun 10).
The drug, which was first created to treat Ebola, has been used as part of clinical trials in Singapore for COVID-19 patients.
Created by Gilead Sciences, the drug was given the go-ahead by HSA after consulting with its Medicines Advisory Committee.
The approval means doctors can now use remdesivir to treat adult COVID-19 patients who require supplemental oxygen or require more intensive breathing support, such as the use of ventilators or life support machines.
Patients who have oxygen saturation levels of 94 per cent or less can also be given the antiviral drug.
“To optimise the use of remdesivir in COVID-19 management, HSA is working with the Ministry of Health (MOH) and relevant experts to further define the subcategory of patients who are likely to benefit most from this medicine,” the authority added.
“Although the data on its efficacy and safety is very limited at this point in time, HSA has expedited the review of remdesivir given the urgent public health need during the COVID-19 pandemic.”
As part of the conditional approval, Gilead, which has an office in Singapore, is required to collect the relevant safety data and monitor the use of the drug.
HSA will also require data from ongoing clinical studies to be submitted after approval, to ensure the “safety and efficacy of the product”.
“Singapore is among the earliest countries to grant an approval for the medicine,” the authority said.
Remdesivir has been used in clinical trials in Singapore since March this year. On May 22, Gilead filed for registration of remdesivir in Singapore and obtained HSA’s conditional approval on Wednesday.
Other drugs used in clinical trials to treat COVID-19 patients in Singapore include anti-HIV drugs lopinavir and ritonavir.
WHAT IS REMDESIVIR
Dr Shawn Vasoo, clinical director at the National Centre for Infectious Diseases (NCID), told CNA previously that while there were “no proven therapies” for the coronavirus, remdesivir was among the drugs trialled as a possible treatment for COVID-19 patients.
The drug has been described by the World Health Organization as one of the most promising therapies against COVID-19.
Remdesivir was granted emergency use authorisation by the US Food and Drug Administration (FDA) on May 1 for severe COVID-19 cases. Japan has also “fast-tracked” a review of the drug and approved use of it.
The antiviral medication was initially created to treat Ebola, but a major trial of remdesivir in the Democratic Republic of Congo was halted last year because it did not boost survival rates among Ebola patients as greatly as two monoclonal antibody drugs.
But in February this year, the US' National Institute of Allergy and Infectious Diseases said it was dusting off remdesivir to investigate how it would react against SARS-CoV-2, the pathogen that causes COVID-19.
A trial of about 1,000 patients around the world showed that remdesivir had a “clear-cut, significant, positive effect” in COVID-19 patients’ recovery time, infectious diseases expert Dr Anthony Fauci told the White House in April.
But a trial of the drug in Wuhan, China – the epicentre of the pandemic – showed there were no benefits in terms of recovery time or mortality for COVID-19 patients. The Chinese trial was stopped prematurely as it could not get enough participants.