Japan asks US for stable remdesivir supply as Tokyo rushes approval

Sunday, 03 May, 2020

Anthony S. Fauci, the Institute's director and the government's leading infectious-disease doctor, said in an interview that the reduction in time to recovery was "highly statistically significant".

"Will it be an overwhelming cure?" But with its use, "you will free up hospital beds, you will take less stress on the health care system".

Gilead said that ICU hospitals and hospitals that the federal government decides are most in need of the drug will have priority in receiving their limited supply of remdesivir.

Gilead said earlier this week it has about 50,000 courses of the drug ready to distribute.

Here are some questions about the results and next steps.

These types of studies can reduce some biases that can influence studies, but also help quantify the effectiveness of the drug. In addition, the results suggested a possible survival benefit: Remdesivir was associated with a mortality rate of eight percent, compared to 11 percent with the placebo.

Q: What about folks with milder illness?

"That's been the hot thing in the papers and in the media for the last little while - an important treatment for hospitalized coronavirus patients", Trump said.

Under the emergency use authorization, remdesivir will be distributed in the United States and administered intravenously by health care providers for patients with low blood oxygen levels as well as those needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.

Q: When will it be available and for whom? Therefore, the FDA has authorized the emergency use of remdesivir for the treatment of COVID-19 under an EUA, said the agency.

Under law, the FDA may issue an EUA if "it is reasonable to believe that the product may be effective" and "the known and potential benefits outweigh the known and potential risks".

In other news, the Trump Administration's new White House press secretary gave her first briefing on Friday afternoon.

Q: How much remdesivir is there and what will it cost?

Gilead spent $50 million on the research and development of remdesivir during the first quarter, the company disclosed in its earnings report Thursday.

Q: How might having a treatment affect the impact of the pandemic?

"We're all focused on making sure we make this accessible and affordable to patients around the globe", O'Day said.

Q: What about other drugs in testing?

Moreover, Egypt contacted the Japanese manufacturer of the antiviral drug Avigan to treat patients.

"The drug has been introduced only on a trial basis in the USA, however we still need more information before it can be considered for mainstream use to treat those affected with COVID-19", states Dr Nagaraja, Director of the Rajiv Gandhi Institute of Chest Diseases in Bengaluru, adding that there needs to be more concrete evidence before the drug can be considered for widespread use in India.