Coronavirus drug remdesivir gets conditional approval in Europe

Remdesivir Coronavirus COVID-19 Coronavirus drug COVID-19 drug Cipla antiviral drug Hetero United States Food and Drug Administration USFDA Emergency Use Authorisation EUA Drug Controller General of India DCGI Jubilant Life Sciences Gilead

The European medicines Agency (EMA) recommended conditional approval on sale anti - virus product ramdevpir as a drug for the treatment of COVID-19. Authorized for emergency use in the US, India, Singapore, and approved for use in Japan for severe symptoms. The U.S. FDA issued an Emergency Use Authorization (EUA) to Gilead Sciences Inc. for emergency use of remdesivir for the treatment of hospitalized 2019 coronavirus disease (COVID-19) patients.

Cipla shares towered over 9 percent to hit a career-high on Monday after the company informed stock exchanges that it had received approval from the government's Drug Controller General of India (DCGI).

A study by the National Institutes of Health has shown that the drug shortened hospital stays from 15 to 11 days and improved chances for survival. This effect was not observed in patients with mild and moderate course of the disease: time to recovery was 5 days for both group of ramdevpir, and for the placebo group. Currently, remdesivir is given to COVID-19 patients intravenously through daily infusions in the hospital.

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Maharashtra and Delhi, by now confirmed to be the two worst-affected states in the country from coronavirus, is among the five states to receive 20,000 vials of the experimental COVID-19 drug Remdesivir. This study had inrolled 1,063 patients at 47 sites in the United States and 21 global sites. Data from these studies shows that remdesivir has the potential to be of meaningful benefit to patients with COVID-19.

O'day also pointed out the NIAID study indicated treatment worked best in patients who did not yet need ventilation, indicating further study in patients in the early stages of the disease was warranted.

The drug was also used in the treatment of Ebola but was discontinued after "two other investigational treatments in the trial were associated with greater survival", said Gilead in an earlier release (pdf). However, Reuters reported the drug could be priced up to $5,080 per course in the us, while Indian generic drugmakers could sell treatments for 5,000 to 6,000 rupees ($66.13-$79.35).

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