HSA Grants Conditional Approval of Remdesivir for Treatment of COVID-19 Infection
The Health Sciences Authority (HSA), in consultation with its Medicines Advisory Committee, has today granted conditional approval for Gilead Sciences Singapore Pte Ltd’s (Gilead) Veklury® (remdesivir). This will allow infectious diseases specialists to administer remdesivir for the treatment of adult patients with COVID-19 infection, who:
- 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.
2 To optimise the use of remdesivir in COVID-19 management, HSA is working with the Ministry of Health and relevant experts to further define the subcategory of patients who are likely to benefit most from this medicine.
3 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 is required to collect the relevant safety data and to monitor the use of remdesivir. HSA will also require data from ongoing clinical studies to be submitted post-approval to ensure the continued safety and efficacy of the product.
4 Since March 2020, HSA had facilitated the early access of remdesivir to COVID-19 patients in Singapore through the expeditious evaluation and approval of its use in clinical trials. HSA has been working closely with Gilead on the conditional approval of remdesivir in Singapore. Gilead filed for registration of remdesivir in Singapore on 22 May and obtained HSA’s conditional approval on 10 June 2020. Singapore is among the earliest countries to grant an approval for the medicine.
HEALTH SCIENCES AUTHORITY
10 JUNE 2020