Remdesivir Gets Clinical Approval: How Does It Cure COVID-19 And Is It Used In India?
The US FDA has allowed the emergency use of experimental antiviral drug ¡®Remdesivir¡¯ to treat COVID-19 patients after early clinical data showed that it is helping COVID-19 patients to recover faster.
The drug has been developed by Gilead Science -- a pharmaceutical company based out of California in the United States.
As of now, the IP (intellectual property) for the drug is with Gilead Sciences. Indian pharma companies don¡¯t really have access to the IP of the drug yet, but they¡¯re working with pharmaceutical companies across the globe to create licensing agreements so that they can make their version of remdesivir to treat people in the country.
As crazy as this sounds, remdesivir was originally made to cure Ebola -- another deadly virus. However, it never really got FDA approval for the same. The drug has also shown promise against MERS and SARS -- kinds of coronaviruses that hinted towards its effectiveness against COVID-19.
Remdesivir is essentially a nucleoside analogue. It is known to compete with ATP (adenosine triphosphate) during the production of viral RNA. We already know that enzyme called RNA polymerase makes new RNA copies which are then used to make new viruses. Remdesivir, when it replaces the ATP during the formation of RNA, completely breaks the link in the replication process, halting virus replication and saving the patient¡¯s life.
The most recent study conducted by the National Institutes of Health involving 1,063 patients revealed that people who were put on remdesivir recovered 31 percent faster than those who were prescribed a placebo. Remdesivir also lowered the mortality rate compared to the placebo group, from 11.6 percent to 8 percent.
Another study conducted internally by Gilead involved 397 patients that divided them into two groups -- one treated for 5 days while the other for 10 days. The study revealed that the drug was equally effective over five days of use as it is over 10. This basically meant that the drug was effective in low and high doses, meaning it can be offered to more patients. However, the study lacked a placebo treatment, that made it slightly difficult to compare its overall impact.
Not particularly.? A randomised trial of the drug (published in lancelet) showed no betterment in the healing of the patients. This suggests that more tests are crucial to strengthen its efficacy claims.?
Remdesivir, even though is temporarily approved for use by US FDA, has a list of side effects including, increase in the levels of liver enzymes, that indicate it could harm the liver. It is also surrounded by Infusion-related reaction during the administration of the drug which shows up as nausea, vomiting, shivering, sweating and low blood pressure.
Recently. Union Minister Dr Harsh Vardhan has revealed in a report that it has received 1000 samples of remdesivir and will soon commence testing it on patients suffering from COVID-19, as a part of WHO¡¯s solidarity trial. Union minister has also revealed that discussions are underway with scientists at ICMR and CSIR to soon bring this medicine in the hands of doctors to treat COVID-19.