US FDA allows use of remdesivir drug for severely ill COVID19 patients

Monday, 04 May, 2020

"The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery", he said. President Donald Trump announced the decision on Friday alongside the CEO of Gilead Sciences, Daniel O'Day. And the result of the treatment was an earlier discharge from the hospital, said Clemens Wendtner from Munich Clinic Schwabing later this week.

Health and Human Services Secretary Alex Azar said that this is a significant step forward in battling COVID-19.

Remdesivir, the first possible scientifically proven treatment for battling COVID-19, will become available for US hospitals in the coming week, says the CEO of the biotech company producing the drug.

Trump said that his administration has been doing work with the teams at the FDA, National Institute of Health and Gilead for spearheading this public-private partnership to make this happen very quickly. "It's only been three months since the first case was diagnosed in the United States to the emergency use authorization that was provided this past Friday". Those given the drug were able to leave the hospital in 11 days on average versus 15 days for the comparison group.

"NIH, FDA, and scientists across America and around the world have worked tirelessly with patients to get us this new potential treatment for COVID-19".

The Fact Sheet for physicians also suggests a course should be 5 days in non-ventilated patients, extendable to 10 days if there is no clinical improvement, and 10 days in patients on ventilators/ ECMO (extracorporeal membrane oxygenation).

Emergency FDA authorisation is not the same as formal approval, which requires a higher level of review.

Gilead Sciences will get its antiviral drug remdesivir to patients as soon as this week, Chief Executive Officer Daniel O'Day said, just days after the United States approved emergency use for people with COVID-19.

Fauci further admonished clinical trial researchers to stop further tests on patients placed on placebo so that they too could access the real drug since it is now proven to reduce hospitalization.

The Institute for Clinical and Economic Review, a U.S. body which studies drug prices, estimated the cost of a 10-day course of remdesivir at $10 (£8), but suggested a cost-effective price could be as much as $4,500, based on the clinical trials.

"We have been exporting for clinical trials and for compassionate use thousands of treatment courses", O'Day said on CBS's "Face the Nation".

"This (remdesivir) is a direct-acting antiviral". Instead, the government is proceeding with clinical trials.

The government, however, has not applied the special approval system to the flu drug Avigan, because its sales prospects overseas are unclear. The drugmaker said the findings were inconclusive because the study was terminated early. The Indian Council of Medical Research is examining new therapeutic options for Covid-19 patients.

IndiaToday.in has plenty of useful resources that can help you better understand the coronavirus pandemic and protect yourself. Catch the latest TV debates and video reports here.