Gilead: Remdesivir helped moderate patients improve

Henrietta Brewer
June 3, 2020

The regulator has decided against extending the use of the drug to 10 days, based on existing evidence presented to it at the time of approval, according to the paper.

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.

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

However, Dr. Somani did consult the expert committee of the Central Drugs Standard Control Organization he heads before clearing the medication. "The drug is given in the form of an injection and that is why it has to be administered under the supervision of a doctor in a hospital setting", the source said. Meanwhile, applications of two Indian pharmaceutical companies - Cipla and Hetero Labs - seeking permission to manufacture and sell remdesivir in India is still under consideration.

The trial looked at the impacts of five-day and 10-day drug-treatment courses, along with standard care, in patients with moderate COVID-19 pneumonia, compared to standard care alone.

In COVID-19 patients receiving treatment with intravenous remdesivir for 5 days in addition to standard treatment, odds of showing clinical improvement at day 11 were 65% higher (95% CI 9%-148%, P=0.017) versus those receiving standard of care, reported manufacturer Gilead Sciences in a press release on Monday.

This difference in improvement was only significant in the group receiving 5 days of remdesivir, with a non-significant difference among patients receiving 10 days of the drug (OR 1.31, 95% CI 0.88-1.95, P=0.18).

After being given emergency approval in May for use in hospitalized patients, the California-based company announced that it had donated its entire supply of the drug to the USA government to be distributed to "vulnerable" cities with patients that need the medicine, McClatchy News reported. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.

Roche RHHBY too initiated a late-stage study on its arthritis drug, Actemra/RoActemra, in combination with remdesivir in hospitalized patients with severe COVID-19 pneumonia. The maker of remdesivir on Monday published an additional study on Monday that says that remdesivir works in COVID-19 therapies. The placebo-controlled study conducted by the National Institute of Allergy and Infectious Diseases demonstrated that remdesivir enabled more rapid recovery and that earlier treatment improved outcomes in patients with a range of disease severity.

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