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

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.

FILE PHOTO: Gilead Sciences Inc pharmaceutical company is seen after they announced a Phase 3 Trial of the investigational antiviral drug Remdesivir in patients with severe coronavirus disease (COVID-19), during the outbreak of the coronavirus disease (COVID-19), in Oceanside, California, U.S., April 29, 2020. REUTERS/Mike Blake/File Photo

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.

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.

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

Earlier this week, Gilead said remdesivir 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.

The DCGI had 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 on Tuesday, citing sources.

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

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

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

“While there is currently limited global supply of remdesivir, the company anticipates new supply of the drug to start to become available in July,” the drugmaker said.

Governments are racing to bolster supplies of remdesivir, with European and South Korean authorities vying for the potential COVID-19 treatment.

Reporting by Anuron Kumar Mitra and Manas Mishra in Bengaluru; Editing by Louise Heavens and Arun Koyyur

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