COVID-19 drug | No approval yet for Indian companies to market remdesivir


India's drug regulator has granted USA pharma giant Gilead Sciences marketing authorisation for its anti-viral drug remdesivir for "restricted emergency use" on hospitalised Covid-19 patients in view of the crisis posed by the pandemic.

Representational image. A report suggests that this drug can be procured only by government hospitals and cannot be sold to any individual for self-medication as it is under clinical trial. It must be noted that Remdesivir is the first drug to show some improvement in Coronavirus patients in clinical trials.

The drug has been approved for the treatment of adults and children with severe COVID-19, the Indian Express newspaper reported on Tuesday, citing sources. Even though the results indicated the drug responds better than most of the standard medicine prescribed to patients, epidemiologists were expecting a significant improvement in patients under the drug, which did not prove to be the case. One of them is remdesivir, the drug that received Dr. Anthony Fauci's endorsement in late April.

A separate study published in The New England Journal of Medicine had also found that two out of three critically ill COVID-19 patients who were on oxygen support showed signs of improvement with Remdesivir.

The US authorised the emergency use of remdesivir in hospitals at the start of May, followed by Japan, while Europe has been considering following suit.

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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.

"There seems to be growing evidence five-day treatment is as good or better than 10-day - somewhat curious given no clear side effect liabilities and may seem counterintuitive to the typical "more is better" expectation", said Brian Abrahams, an analyst with RBC Capital Markets.

However, the odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care alone were favorable but did not attain statistical significance. There is also a potential risk of the mortality rate increasing with extended use, so the authority has been more stringent with its decision compared to other countries. Shares are now trading up 16% year-to-date.

"[Remdesivir] approved on June 1 under emergency use with condition for five dose administration", said the Drugs Controller General of India, the government regulator.

As for the second reason, it cited other countries such as the US, Japan and the United Kingdom which are allowing the use of remdesivir to treat COVID-19.