The United States Food and Drug Administration on Thursday approved antiviral drug remdesivir for treating hospitalised coronavirus patients. The Gilead Sciences-manufactured drug is the first and only medicine to be approved for the coronavirus in the country.
In May, the drug had only been granted emergency-use approval in the US. It was also one of the drugs used to treat President Donald Trump when he tested positive for the infection in early October.
The Food and Drug Administration issued instructions on how to administer the medicine. It said that the medicine should be used for “adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms for the treatment of Covid-19 requiring hospitalisation”.
The federal agency said the drug can only be given to patients in a hospital or equivalent setting.
The World Health Organization, however, found last week that the drug failed to reduce deaths among patients or cut the duration of their treatment in hospitals.
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WHO had conducted a “Solidarity Therapeutics” trial to study the effectiveness of remdesivir, anti-malarial drug hydroxychloroquine, anti-HIV drug combination lopinavir/ritonavir, and interferon. It involved 11,266 patients across over 30 countries.
Another study conducted earlier this month showed that remdesivir reduced patients’ recovery time by five days.
Several countries have authorised remdesivir for Covid-19 treatment. In India, Gujarat based-firm Zydus Cadila had signed an agreement with Gilead Sciences to produce and sell the medicine. The firm had launched its version of the medicine in August, at Rs 2,800 for a 100 gram vial. Apart from Zydus Cadila, Hetero Labs, Cipla, Mylan NV and Jubilant Life Sciences also produce the drug in India.
The coronavirus has infected more than 4.16 crore people globally and killed 11,37,204, according to Johns Hopkins University. US is the world’s worst-affected country with over 84 lakh cases and more than 2.23 lakh deaths.