The Ministry of Food and Drug Safety (MFDS) said that it has granted emergency use approval (EUA) to expand the treatment range of remdesivir, a Covid-19 treatment developed by Gilead Sciences.

The Ministry of Food and Drug Safety has expanded the emergency use approval treatment criteria for Gilead Sciences’ Covid-19 treatment, remdesivir.
The Ministry of Food and Drug Safety has expanded the emergency use approval treatment criteria for Gilead Sciences’ Covid-19 treatment, remdesivir.

Hospitals now use the treatment for patients under 12 weighing 3.5 to 40kg with severe pneumonia who require supplemental oxygen treatment. However, the EUA will allow them to use it in treating mild to moderate adult and pediatric patients over 12 years or weighing over 40 kg and with a high risk of progression to the dosing range.

The expanded EUA follows the regulator’s previous decision to change the medication scope of remdesivir to inpatients 12 years of age or older and children weighing 40 kg or more with pneumonia who require supplemental oxygen treatment.

“The ministry decided to grant the EUA expansion after a comprehensive review of clinical trial results for mild to moderate patients, European approval cases, expert advice, and committee deliberation,” the MFDS said. “We will continue to review and approve medical products for emergency use based on our expertise in regulatory science.”

The ministry added that it would strive to quickly supply safe and effective products to overcome Covid-19 and restore people to their daily lives.

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