HSA grants conditional approval for remdesivir as treatment in severe COVID-19 cases

The Health Sciences Authority (HSA) has granted conditional approval for remdesivir as a means of treatment in serious cases of COVID-19 infection.

The approval was made in consultation with its Medicines Advisory Committee.

Remdesivir, which is produced by United States pharmaceutical manufacturer Gilead Sciences, may be used in cases where adult COVID-19 patients:

• Have oxygen saturation less than or equal to 94%, or;
• Require supplemental oxygen, or;
• Require more intensive breathing support such as extracorporeal membrane oxygenation or invasive mechanical ventilation.

HSA in a statement on Wednesday (10 June) said that it 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.

Touching on the conditional approval, HSA said that it was given based on “the urgent public health need during the COVID-19 pandemic” in spite of the limited data on remdesivir’s efficacy and safety currently.

Gilead, said HSA, will be required to collect the relevant safety data and to monitor the use of the drug.

“HSA will also require data from ongoing clinical studies to be submitted post-approval to ensure the continued safety and efficacy of the product,” added the Authority.

HSA added that it has facilitated the early access of remdesivir to COVID-19 patients in Singapore through “the expeditious evaluation and approval of its use in clinical trials” since March.

Singapore is among the earliest countries to grant an approval for the medicine, the Authority noted.