In the run to develop a vaccine or even a treatment for Covid-19, the US FDA has approved the usage of remdesivir as an emergency treatment option for Covid-19. The drug has been under clinical trials and has shown impressive results in helping patients recover faster.
US President Donald Trump announced this new breakthrough at the White House along with the FDA commissioner Stephen Hahn, who informed that the drug is going to be available for the patients who are hospitalised with Covid-19.
The FDA approved this following the success rate from the government sponsored study from Gilead Sciences that found that the drug was successful in shortening the recovery time by 31%. This cut down the recovery time by four days in the patients.
The study included 1063 patients and was one of the strictest drug testing with a control group for comparison.
The researchers found that the patients who received remdesivir were able to leave the hospital in 11 days which is normally 15 days otherwise. The drug is also believed to be reducing deaths as well, although that hasn’t been confirmed yet.
Even Dr Anthony Fauci reported that the drug is going to become the new standard care for all the severely ill Covid-19 patients. The drug is yet to be tested on the patients showing milder symptoms of the disease.
The FDA approved the emergency use of the drug for quick experimental trials for the medical products during this moment of crisis.
In other times, the FDA requires substantial evidence for the drugs to be then administered to the patients who are in need of the same. But, since the world is under a public health emergency, it can waive off those requirements.
Gilead even reported that they are going to donate 1.5 million vials of the drug and are working to increase the production even more.
This is just an early stage and no drugs have been approved yet as a formal treatment option for Covid-19. Even remdesivir will have to get the formal approval.
FDA is likely going to convert the status of the drug and give full approval in case Gilead successfully provide more data surrounding the safety and the effectiveness of the drug.
“This is a very, very early stage so you wouldn’t expect to have any sort of full approval at this point,” Cathy Burgess, FDA attorney suggested.
FDA has primarily also given emergency authority to the anti-malaria drug, hydroxychloroquine following Trump’s constant promotion of the drug and its possible effectiveness in the treatment of the disease.
No high quality tests or trials have proven the effectiveness of this drug for the treatment of Covid-19.
The FDA also warned the doctors in not prescribing the medication outside of hospital or research settings as they also come with the side effects of possible heart attacks.
When Gilead was conducted surrounding the profits that they are going to earn from the Covid-19 medication, they failed to report whether they want to donate the medication or gain profit from it.
