Conditional approval of Veklury® (SBECD-enabled remdesivir) for COVID-19 infection in Singapore

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The Health Sciences Authority (HSA), in consultation with its Medicines Advisory Committee and infectious diseases experts informed healthcare professionals on the conditional approval of Veklury® (remdesivir) for the treatment of COVID-19 patients. Given the urgent public health need during the COVID-19 pandemic, HSA has expedited the review of remdesivir based on its very limited efficacy and safety data and will require more data to be submitted to HSA post-approval to ensure the continued efficacy and safety of the product. To optimise the use of remdesivir in COVID-19 management, the use of Veklury® is currently restricted to Infectious Diseases physicians and guidelines on the appropriate use of remdesivir in healthcare institutions will be developed by MOH and NCID to address the subcategory of patients who are likely to benefit most from the drug. HSA will continue to monitor the benefit-risk profile of Veklury® and provide updates to healthcare professionals as necessary. Healthcare professionals are required to report any suspected serious adverse reactions observed with the use of remdesivir to HSA.

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