Gilead Science Inc's GILD.O antiviral drug remdesivir was granted emergency use authorization by the U.S. Food and Drug Administration for COVID-19 on Friday, clearing the way for broader use of the drug in more hospitals around the United States.
Preliminary results indicate that patients who took remdesivir recovered 31 percent faster than those who took the placebo, shortening the median recovery time from 15 days to 11 days. A USA -led study released this week showed that patients who got the drug recovered in an average of 11 days, while those who get a placebo recovered in 15 days. The drug may also help avert deaths, but that effect is not yet large enough for scientists to know for sure.
Nonetheless, this week the NIAID or National Institute of Allergy & Infectious Diseases released data from clinical trials showing that the drug enabled a shorter recovery time for some COVID-19 patients. However, subsequent testing suggested the drug had the ability to treat viruses with similar mechanisms of replication, including members of the coronavirus family of viral illnesses that result in respiratory tract infections.
When the federal government declares a public health emergency, the FDA can approve drugs or tests to address the emergency if there are no alternatives. Dr. Anthony Fauci, who heads the NIAID, nevertheless cheered the drug as having a "clear-cut, significant, positive effect in diminishing the time to recovery".
Kato told reporters that he understands the drug company will submit an application soon, and that he had instructed his staff to get it approved in about a week. Experts said though the trial is significant as it is suggestive of reduction in symptomatic time, it can not be used as a standard treatment because of limited evidence.
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He received the National Film Award for his debut role as a child artist in his father Raj Kapoor's 1970 film Mera Naam Joker. "Our dear Rishi Kapoor passed away peacefully at 8:45 am IST in hospital today after a two-year battle with leukaemia".
"We understand our responsibility both to patients and also to shareholders and we'll be balancing that", he said during an interview with CNBC's "Squawk Box".
He recalled AZT, the first drug shown to help people with HIV, the virus that causes AIDS. Some patients were given the drug and others were given a placebo (dummy) treatment.
Remdesivir was developed by USA biopharmaceutical company Gilead Sciences as a possible treatment for Ebola, but it has not been licensed or approved anywhere globally.
Tracey said one clinical trial targets patients who appear moderately ill with the virus, while the other is for patients in the ICU with lung failure and low oxygen levels.
Hahn said the drug's approval for emergency use represented "an important clinical advance" in the fight against coronavirus. Clinical trials have been under way to confirm the effectiveness and safety of its use for COVID-19 patients around the world, including Japan.