- The US Food and Drug Administration (FDA) has approved the Veklury (Remdesivir) drug to treat COVID-19.
- This is the first and only treatment so far to receive the American drug regulator’s approval for Covid-19.
- Remdesivir has been approved or authorised for temporary use as a Covid-19 treatment in nearly 50 countries, including India.
- However, the interim results of WHO’s solidarity trials recently showed that the drug was ineffective in reducing mortality (death) or duration of hospital stay.
- Earlier in May, the US FDA had issued an Emergency Use Authorisation (EUA) for Remdesivir, which meant that it could be used for patients who were hospitalised and were experiencing severe conditions due to the disease.
- Then in August, it extended the EUA to include treatment of suspected and laboratory-confirmed hospitalised patients irrespective of disease severity.
Functioning of Remdesivir
- Remdesivir is designed to block the replication (multiplication) of the virus in the body.
- When the novel coronavirus enters the body, it releases a genetic material, which is then copied using the body’s mechanism.
- At the replication stage (copying stage), there is an enzyme called RdRp that makes copies of the virus and enables it to spread.
- When a patient is given remdesivir, it mimics (imitates) some of this material and locates itself at the replication site.
- As remdesivir replaces the material that the virus needs to replicate, the virus fails to replicate further.
Possible side-effects of Remdesivir
- Possible side-effects of Remdesivir include increased levels of liver enzymes, which can be a sign of liver injury, allergic reactions, changes in blood pressure and heart rate.
- It can also lead to low oxygen blood levels, fever, shortness of breath, wheezing, rash, nausea, swelling of the lips, around eyes or under the skin and sweating or shivering.
- FDA’s approval does not cover the entire population. It has approved the use of the antiviral drug only to treat hospitalised adult and paediatric 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.
- Acute care is the level of care in the health care system that consists of emergency treatment and critical care.
FDA’s drug approval process
- Approval of a new drug requires strong evidence of its effectiveness and a demonstration that it is safe for use by the patients.
- Thus, to approve a drug, the agency conducts a benefit-risk assessment that is based on scientific standards.
Studies used for the approval of Remdesivir by US FDA
- Therefore, the FDA approved Remdesivir after it analysed data from three 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.
- Th trial compared 10 days of treatment with Remdesivir versus the treatment with a placebo. A placebo is a pill or a treatment that seems to be a “real” medical treatment but it has no medicinal value.
- 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.
- Moreover, the chances of clinical improvement at day 15 were also significantly higher in the Remdesivir group when compared to the placebo group.
Other types of treatments for COVID-19 under study by the FDA
- The FDA is studying over five different treatment types for COVID-19 as follows:
- Antiviral drugs (such as remdesivir): To 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.
- Immunomodulators: Supposed to control the body’s immune response from increasing beyond the required levels.
- Neutralising antibody therapies: To help the infected individual to fight the virus with the help of manufactured antibodies or animal-sourced antibody therapies.
- Cell therapy (cellular immunotherapy): It is a form of treatment that uses the cells of the immune system to fight a disease.
- Gene therapy: It replaces a gene that causes a medical problem with a gene that doesn’t cause any problem, or adds genes to help the body to fight or treat diseases, or turns off genes that are causing problems.
Status of Remdesivir in India
- The drug is approved only for restricted emergency use at present in India.
- According to experts, the FDA approval may not lead to its approval or increase in its usage in India.
- The future of the drug is still being assessed in India, especially after the interim results of the WHO-sponsored Solidarity Therapeutics trial.
- The United States Food and Drug Administration is a Federal agency of the Department of Health and Human Services.
- The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products and medical devices.
- It also performs control and supervision of food safety, tobacco products, dietary supplements