European Union agency recommends 1st COVID-19 treatment

Five Indian States To Receive Coronavirus Drug

The drug might be obtainable exclusively by means of hospitals and authorities, and never the retail channel, PTI reported quoting Hetero Group of Companies MD Vamsi Krishna Bandi.

So far, the only drug that has reduced mortality in COVID-19 is dexamethasone, a low-priced generic steroid that cut the death rate for the most seriously-ill patients by 41% at 28 days in the large-scale RECOVERY trial. Those who received the treatment recovered, on average, four days sooner than those who received a placebo.

Amidst this, several studies have found that anti-viral drug Remdesivir could be used in the treatment of COVID-19 patients.

An inhaled formulation of the drug will be administered via a nebulizer, which would allow for use outside of hospitals.

Regulator Drug Controller General of India (DCGI) has permitted the generic variations made by Cipla and Hetero for restricted emergency use in extreme COVID-19 instances.

"FDA's emergency authorization of remdesivir, two days after the National Institutes of Health's clinical trial showed promising results, is a significant step forward in battling COVID-19 and another example of the Trump Administration moving as quickly as possible to use science to save lives", HHS Secretary Alex Azar had said in a statement.

M. Srinivasa Reddy, managing director, Hetero Healthcare Limited said: "Covifor is the first generic brand of Remdesivir which is indicated for the treatment of COVID-19 patients".

"As part of a risk management plan, Cipla will provide training on use of the drug, informed patient consent documents, conduct post marketing surveillance as well as conduct a Phase IV clinical trial on Indian patients", the company said in a statement.

In an open letter, the firm's chairman and chief executive Daniel O'Day said health volunteers would be screened for participation in a Phase I trial this week, now scheduled for August.

The firm will also study the potential of combining remdesivir with two immune modulators - the JAK inhibitor baricitinib, and the IL-6 receptor antagonist tocilizumab.

"Last week's news on dexamethasone appears to further support the study of complementary approaches for treating COVID-19". - Daniel O'Day, Chairman & CEO, Gilead Sciences.



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