Taiwan approves remdesivir as COVID-19 medication
ROC Central News Agency
05/30/2020 04:34 PM
Taipei, May 30 (CNA) Taiwan's health authorities have approved the potential new coronavirus COVID-19 medication remdesivir for treatment of the disease in the country, the Central Epidemic Command Center said Saturday.
At a daily press briefing, Wu Shou-mei (吳秀梅), Director-General of Taiwan's Food and Drug Administration (FDA), said that a panel of experts which met on Friday found that the drug was needed in Taiwan and agreed that it should be used to treat severe patients infected with COVID-19.
Taiwan plans to order doses for 1,000 patients, with the order expected to arrive late July, Wu said, adding that the move is to ensure there is enough medication for severely ill patients if a second wave of infection occurs.
The expert panel came to a consensus that remdesivir can be approved in Taiwan under Article 48-2 of the Pharmaceutical Affairs Act, which states that the drug can be manufactured or imported as a "special case," Wu said.
The longest period of treatment with remdesivir will be 10 days, with different dosages for people of different weights, Wu added.
After the drug is available for use, the suppliers will still need to implement a risk management plan to ensure patient safety, Wu said.
"At the moment, even though clinical testing is still being carried out, it (remdesivir) is the drug we have seen so far that shows more promising results," Wu said.
Due to the emergency of the situation, Taiwan needs to quickly approve the drug for its patients, Wu said.
Remdesivir was given an emergency use authorization in the United States on May 1 and was also given a special approval for emergencies in Japan on May 7, Wu said.
Taiwan's FDA received an application by remdesivir's supplier on May 25, and will officially issue a permit for the drug sometime next week, Wu said.
The broad-spectrum antiviral medication, developed by American-based biopharmaceutical company Gilead Sciences, Inc., has made headlines around the world as gaining emergency authorization in countries treating patients infected with the coronavirus.
To date, Taiwan has recorded 442 cases of the disease, with seven deaths, the CECC has reported.
(By William Yen)
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