The treatment drug remdesivir showed promise for moderately ill coronavirus patients in a recent trial, the drug's maker says. (GILD) remdesivir, which is administered intravenously in the hospital, was the first drug to show improvement in Covid-19 patients in clinical trials.
CDCSO after consultation with an expert committee has granted the Remdesivir drug only to be given in emergencies in laboratory-confirmed COVID-19 patients in India.
It is approved for treating COVID-19 in Japan and is authorized for emergency use in the United States for certain patients.
The company-led study involved almost 600 patients who had moderate pneumonia but did not need oxygen support.
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).
A late-stage trial evaluated patients in 5-day and 10-day courses, but the latter did not show statistical significance. Nausea and headache were a little more common among those on the drug.
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In a note to investors, Evercore ISI analyst Umer Raffat noted that the study's main goal was changed partway through, from the percentage of patients discharged within two weeks to the scale of improvement after 11 days.
In other words, remdesivir therapy can be helpful, but there's still no evidence that the drug can prevent complications, which is a key objective for COVID-19 treatments.
South Korea's food and drug administration on Wednesday made an emergency decision to allow the use of remdesivir as a treatment for the new coronavirus, paving the way for inbound shipments of the new drug for the first time.
In the short term, Gilead is studying how its existing IV formulation of remdesivir can be diluted for use with a nebulizer - a drug delivery device used to administer medication in the form of a mist inhaled into the lungs.
Meanwhile, The National Institute of Allergy and Infectious Diseases' placebo-controlled study showed that remdesivir enabled more rapid recovery and early treatment improved clinical outcomes.
The ministry said it will cooperate with Gilead, the Korea Centers for Disease Control and Prevention and other ministries to swiftly import the drug.