India and South Korea approve Gilead’s remdesivir for emergency use against COVID-19

pharmafile | June 3, 2020 | News story | Research and Development, Sales and Marketing COVID-19, Gilead, India, coronavirus, remdesivir, south korea 

India and South Korea have moved to follow in the footsteps of the US in approving Gilead’s antiviral therapy remdesivir for emergency use in a bid to fight the ongoing COVID-19 pandemic.

India’s Central Drugs Standard Control Organisation (CDSCO) has approved five different doses of the therapy for the treatment of hospitalised adult patients and children with “severe” manifestations of the disease. The decision was taken under the New Drug and Clinical Trial Rules legislation of 2019, and it is to be used in a regimen lasting up to five days, but not up to ten days, based on available efficacy data.

“As per the data presented by the company so far, administering remdesivir for 10 days as opposed to five doesn’t have any beneficial effects, so why should patients consume it for an additional five days? There is also a potential risk of the mortality rate increasing with extended use, so the authority has been more stringent with its decisions compared to other countries,” a senior Health Ministry official told The Indian Express. “The approval paves the way for generic voluntary licence holders in our country to manufacture remdesivir. The restriction of administration of the drug to five days will save the patients a lot of money.”

Klinera Global Services in Mumbai will import the drug from Gilead’s US manufacturing facilities, as well as contract manufacturing organisations Jubilant HollisterStier and Patheon Manufacturing Services, also in the US.

India has seen over 200,000 cases of the virus, along with over 5,800 deaths.

The following day, South Korea revealed it would be following suit, with the nation’s Ministry for Food and Drug Safety moving to approve the drug for emergency use in treating COVID-19.

“Remdesivir can help reduce the amount of coronavirus in the body,” the Ministry said. “This can help the patient’s condition improve faster.”

Guidance from the Ministry allows for one dose of the drug to be administered per day for five days in moderate cases, but up to ten days in severe cases where oxygen support is needed.

South Korea has been widely praised for its prompt and effective handling of the outbreak through trace, test and treat programmes. At the time of writing, the country has seen 11,590 confirmed cases and 273 deaths.

The regulatory decisions follow the release of new data from Gilead on the drug’s efficacy which show that COVID-19 patients treated with remdesivir in combination with standard of care were 65% more likely to show clinical benefit, compared to remdesivir alone.

Matt Fellows

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