FDA approves antiviral Remdesivir for emergency use in COVID-19 patients

The US Food and Drug Administration approved on Friday an experimental antiviral drug, Remdesivir, for emergency use in COVID-19 patients.

The drug can now be given to patients who are hospitalised with severe symptoms and need supplemental oxygen therapy or a ventilator.

Emergency use authorisation means that unapproved drugs or products that might help treat a life-threatening disease can be used when no approved alternatives are available.

“Remdesivir has not undergone the same type of review as an FDA-approved or cleared product,” the agency said in a statement.

“The FDA decision is based on the totality of scientific evidence available showing that it is reasonable to believe that the product meets certain criteria for safety, performance and labelling and may be effective in treatment of patients during the COVID-19 pandemic.”

Earlier two clinical trials had shown that Remdesivir was effective in shortening the disease duration in hospitalised patients. These were carried out by the US National Institute of Allergy and Infectious Diseases and the other by Gilead Sciences, the company that manufactures Remdesivir.

Remdesivir, which was developed to treat Ebola, isn’t licensed or approved anywhere in the world yet. It belongs to a class of drugs known as nucleotide analogs which can block the production of viral DNA or RNA. This stops the virus from replicating.

Previously it has proved effective against Ebola, Marburg, MERS and SARS both in vitro and in vivo. The approval of Remdesivir is the latest step in a global push to find viable treatments and a vaccine for the novel coronavirus.

The US has reported around 1.1 million confirmed COVID-19 cases and nearly 65,000 deaths, the highest in the world.

from coronavirus – SAMAA https://ift.tt/2Sqcsek