India approves Gilead’s remdesivir to treat severe COVID-19 cases

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BENGALURU (Reuters) – India’s government has approved Gilead Sciences Inc’s antiviral drug remdesivir for emergency use for five doses in treating COVID-19 patients.

Remdesivir, which is administered intravenously in hospital, is the first drug to show improvement in COVID-19 patients in formal clinical trials and is at the forefront of the battle against COVID-19, which has no approved treatment or vaccine.

“(Remdesivir) approved on June 1 under emergency use with condition for five dose administration,” the Drugs Controller General of India said in an email on Tuesday.

Earlier this week, Gilead said the drug showed modest benefit in patients with moderate COVID-19 given a five-day course, while those who received it for 10 days in the study did not fare as well.

“(DCGI) has granted regulatory approval of (remdesivir) for treatment of suspected or laboratory confirmed COVID-19 in adults and children hospitalised with severe disease,” Gilead said in an email on Wednesday.

The drug was granted emergency use authorization by the U.S. Food and Drug Administration last month and has received approval by Japanese health regulators.

Earlier in the day, South Korea approved the drug’s emergency use and said it will cooperate with Gilead for its swift import.

India’s coronavirus infections crossed 200,000, latest official figures showed, with the death toll at 5,815.

The DCGI decided against extending its use to 10 days, based on existing evidence presented to it at the time of approval, the Indian Express newspaper had reported https://bit.ly/3cpFces on Tuesday.

The U.S. drugmaker did not share details on the dosage in its statement.

Gilead had signed non-exclusive licensing pacts last month with five generic drugmakers in India and Pakistan.

“The company anticipates new supply to start to become available in July,” Gilead said.

Governments are racing to bolster supplies of remdesivir, with Europe also vying for the treatment.