FDA approved Remdesivir to treat Coronavirus.
                     FDA APPROVED REMDESIVIR 
TO TREAT CORONAVIRUS
INTRODUCTION
 The US Food and Drug Administration (FDA) approved remdesivir as the first drug to treat 
COVID-19. 
 The drug is designed to obstruct the replication of the virus in the body and has become the 
first drug to get official approval from the FDA for the treatment of the disease.
Source: indianexpress.com
REMDESIVIR
 The FDA has approved the use of the antiviral drug remdesivir to treat hospitalised adult and 
pediatric patients of COVID-19 who weigh at least 40 kg. 
 The agency has clearly stated that the drug should be administered only in hospitals or 
healthcare settings that are capable of providing acute care.
Source: indianexpress.com
What does FDA’s approval for remdesivir mean?
 The agency issued an Emergency Use Authorization (EUA) for remdesivir, which meant that it 
could be used for adult and pediatric patients who were hospitalized and were facing the 
severe disease.
 It extended the EUA to include treatment of suspected and laboratory-confirmed hospitalized 
patients irrespective of disease severity.
Source: indianexpress.com
APPROVED AGE GROUP
 The approval does not cover the entire population that was permitted its use under the EUA. 
 The EUA allows doctors to use the drug even with hospitalized pediatric patients who weigh 
between 3.5-40 kg or are less than 12 years old and weigh at least 3.5 kg. 
Source: indianexpress.com
How does the FDA approve drugs?
 Approval of a new drug requires substantial evidence of effectiveness and a demonstration 
that it is safe for use by the patients. 
 To approve a drug, the agency conducts a benefit-risk assessment that is based on scientific 
standards.
Source: theprint.com
APPROVAL PROCESS
 FDA approved remdesivir after it analysed data from three randomised, controlled phase 3 
clinical trials that included patients who were hospitalised and experienced mild to severe 
COVID-19.
 One of the most important trials among these was the National Institute of Allergy and 
Infectious Diseases (NIAID) sponsored trial that compared 10 days of treatment with the 
antiviral drug versus with placebo. 
Source: vox.com
TRIAL RESULT
 The trial found that for the group that took the drug, the median days to recovery was 11 days 
versus 15 days in the placebo group. 
 Further, the odds of improvement after 15 days of treatment favoured the drug.
Source: cbsnews.com
What are the different types of treatments for COVID-19 
being studied by the FDA?
 The FDA is studying over five different treatment types for COVID-19. These include antiviral 
drugs such as remdesivir that stop the virus from multiplying once it’s inside the body. 
 Such drugs are used to treat diseases including HIV, Herpes and Hepatitis C among others.
Source: indianexpress.com
How does remdesivir act against coronavirus?
 When a patient is given remdesivir, it mimics some of this material and gets incorporated in 
the replication site. 
 With remdesivir replacing the material it needs, the virus fails to replicate further. Remdesivir 
does not prevent deaths in COVID-19 patients, the drug is simply meant to halt the replication 
of the virus. 
Source: indianexpress.com
What are the possible side-effects of the drug?
 Possible side-effects include:
 Increased levels of liver enzymes
 allergic reactions
 changes in blood pressure and heart rate
 low oxygen blood levels
 Fever
 shortness of breath
 Wheezing
 Rash
 Nausea
 swelling of the lips, around eyes or under the skin
Source: indianexpress.com