The Indian drug regulator has granted an Emergency Use Authorisation to Gilead Inc's anti-viral drug Remdesivir for treatment in hospitalised, severe COVID-19 patients. All new drugs have to undergo trials before getting approval for marketing them in India. It must be noted that Remdesivir is the first drug to show some improvement in Coronavirus patients in clinical trials. Only adults and children who are suspected or have laboratory-confirmed cases and show signs of a sever COVID-19 infection will be given this drug for a period of five days.
But confusingly, patients who stayed on remdesivir for 10 days did slightly worse than those who received five days of remdesivir, with only 70 percent of them improving at day 11.
It is approved for treating COVID-19 in Japan and is authorized for emergency use in the United States for certain patients.
The study included 600 patients with moderate COVID-19 cases, including pneumonia, without reduced oxygen levels.
Jefferies equity analyst Michael J. Yee, the JPMorgan biotechnology research team, and the Barclays health care team have all raised doubts over the ability of remdesivir to become the go-to treatment against the virus.
Sources cite that the outcomes of a clinical trial with a 10-day treatment course of remdesivir versus standard of care also showed positive results but did not reach statistical significance.
As for the side effects, the drug was well-tolerated, and the most adverse effects in more than 5% in both groups included nausea and headache.
The open-label phase III SIMPLE study evaluated five-day and 10-day courses of remdesivir plus standard of care as compared to only standard of care in these patients.
Shares of Gilead Sciences extended their decline Tuesday morning.
While the analyst acknowledges a central role for the drug in the treatment of Covid-19, he awaits clarity, on how, when, and for what price remdesivir will be distributed in the U.S. and ex-U.S.
"The drug, which is administered in the form of an injection, has been approved to be sold by retail on the prescription of specialists for use in hospital or institutional setup only", another source told PTI.
Two earlier trials-the National Institute of Allergy and Infectious Diseases' (NIAID) placebo-controlled study and Gilead's own study on severe patients-had shown that 5 days of remdesivir treatment led to significantly clinical improvement among patients by reducing the time to recovery.
"There are limited clinical data available for remdesivir", the release says.
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