Conditional HSA nod for use of remdesivir in serious Covid-19 cases

Drugmaker must collect safety data, monitor drug's use and submit data from ongoing clinical studies

A Gilead Sciences laboratory used in the production of remdesivir, which is given as an intravenous injection to patients and works by blocking an enzyme that is necessary for the Sars-CoV-2 virus to multiply. The Health Ministry and National Centre
A Gilead Sciences laboratory used in the production of remdesivir, which is given as an intravenous injection to patients and works by blocking an enzyme that is necessary for the Sars-CoV-2 virus to multiply. PHOTO: GILEAD SCIENCES

Antiviral drug remdesivir can now be administered to seriously ill Covid-19 patients, making Singapore one of the few countries to get the nod to use it to treat the virus.

The Straits Times has learnt that the Health Sciences Authority (HSA) granted conditional approval yesterday to let infectious disease specialists give the drug to some patients.

Remdesivir, which is produced by US drugmaker Gilead Sciences, is the first drug to bring about improvement in Covid-19 patients in formal trials.

Part of the conditional approval requires Gilead to collect safety data and to monitor the use of the drug. It must also submit data from ongoing clinical studies to HSA to ensure the safety and efficacy of the drug.

The HSA approval was obtained less than three weeks after Gilead filed for registration of remdesivir on May 22.

"While the data on efficacy and safety is limited, the results from the clinical studies provided reasonable preliminary evidence to support a conditional approval," HSA told The Straits Times.

The approval is based on clinical data from the National Institute of Allergy and Infectious Diseases in the United States' global phase three trial and another by Gilead, the firm said in a statement yesterday. National University Hospital (NUH) was one of the international sites for the Gilead-led trial.

Singapore participated in both trials and enrolled about 100 patients, starting on March 12.

Remdesivir was previously available only in such clinical trials.

It is given as an intravenous injection to patients for five to 10 days and works by blocking an enzyme that is necessary for the Sars-CoV-2 virus, which causes Covid-19, to multiply.

It can be administered to patients with low oxygen saturation levels, less than or equal to 94 per cent, or those who might require supplemental oxygen or more intensive breathing support, such as extracorporeal membrane oxygenation (ECMO) or invasive mechanical ventilation.

ECMO is a type of life support involving a machine that takes over the role of the diseased lung and artificially oxygenates the blood outside the body.

While the drug has raised some concerns regarding side effects on the liver and kidney, and rashes during drug infusion, these seem to be contained, said Associate Professor Louis Chai, a senior consultant at the division of infectious diseases at NUH.

The HSA is working with the Ministry of Health (MOH) and relevant experts to further define the sub-category of patients who are likely to benefit most from this medicine, it said.

MOH and the National Centre for Infectious Diseases (NCID) will develop guidelines on the appropriate use of the drug in healthcare institutions. Infectious disease specialists will have access to remdesivir from the NCID.

The authorities are working closely with Gilead to secure supplies of the drug.

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A version of this article appeared in the print edition of The Straits Times on June 11, 2020, with the headline Conditional HSA nod for use of remdesivir in serious Covid-19 cases. Subscribe