The US FDA has approved Gilead Sciences Inc. (NASDAQ:GILD) antiviral therapy remdesivir for the treatment of COVID-19. This makes the drug the first to get approval for treating coronavirus patients that require hospitalization formally.
Remdesivir approved for COVID-19 treatment
In May, remdesivir sold under the brand name Veklury received Emergency Use Authorization (EUA) from the FDA. It was also authorized in Europe and now it has received full approval from the FDA. Remdesivir received EUA after results showed that it could help seriously ill coronavirus patients by shortening hospital stay in some. The company has indicated that studies show that the drug can shorten COVID-19 patients’ hospitalization by around 5 days and seven days for critically ill patients. The drug was used in treating US President Donald Trump early this month when he was diagnosed with COVID-19.
With the approval, the company can now market the drug and talk to patients, doctors, and nurses about its benefits. This will solidify its position as a go-to drug for COVID-19 patients despite other drugs also entering the market. A company statement stated that remdsivir becomes the first and only approved treatment in the US for COVID-19. Although the drug has been in short supply, the company has affirmed that it is currently available in hospitals across the US and has ramped up manufacturing for the drug.
Remdesivir approved despite WHO study indicating it doesn’t reduce fatalities
Interestingly the drug has not shown that it can reduce COVID-19 deaths according to a World Health Organisation study. According to preliminary results released, WHO said that remdesivir and other possible COVID-19 medicines such as hydroxychloroquine had little or no impact in reducing fatalities in COVID-19.
Gilead criticized the WHO study with its Chief Medical officer Merdad Parsey saying that the findings did not negate other findings. The company said that FDA approval was based on three different clinical studies. The FDA also granted the remdesivir EUA in the treatment of Paediatric coronavirus patients below 12 years and weighing not more than 88 pounds.