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  • US FDA Approved Remdesivir As Covid 19 Treatment Plan | Covid 19 Treatment | All You Need To Know About Remdesivir Approval |

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  • FDA approves, but WHO does not agree
  • WHO will issue detailed guidelines in two-three weeks

The Food and Drug Administration (FDA) of the US last week approved Remadecivir as the first drug to treat corona. This drug is designed to stop the virus from growing in the body. It is now the first drug the FDA has approved to treat this infection.

Ever since the pandemic started, there has been a debate about the effectiveness of this medicine. This drug was designed to treat Ebola, which had nothing to do with Corona. Even after the FDA’s approval, the World Health Organization (WHO) reiterated that remadecivir had nothing to do with saving lives. So, be careful in treatment. Let us know what the anti-US-FDA and WHO statements mean. How is FDA approval?

First, what has the FDA said on this treatment?

  • The FDA has approved the antiviral drug Remedisvir to treat hospitalized adults and children weighing more than 40 kg. The agency has clarified that this medicine should be given only in hospitals or health care centers, where there is a capacity to provide acute care.
  • There were no coronavirus treatment plans prior to FDA approval. In May, the agency issued the Emergency Use Authority (EUA) for Remedisvir. That is, Remadecivir was used only for serious patients. In August, the EUA expanded its scope and began to be given common features as well.

What is the FDA’s way to approve a drug?

  • The FDA said in May guidelines that the drug should be randomized, placebo-controlled, double-blind trials to prevent or treat corona. Evaluation should be based on the data coming from it.
  • There are two important conditions for approving a new medicine – effectiveness and safety. The US-FDA makes a benefit-risk assessment before approving a drug. It is based entirely on scientific standards. Remadecivir also had to go through this process.
  • The National Institute of Allergy and Infectious Diseases (NIAID) observed in its trials that patients who were given this medicine were cured within 11 days. Patients were taking 15–16 days in general. This means that Remedisivir reduces the recovery time by 5 days.
  • Gilead sponsored the second and third trials. Safety and effectiveness were also investigated in this. People who did not have severe symptoms, supported a 5-day treatment plan. At the same time, the results came out the same in serious patients.

How many types of treatments are the FDA studying for corona?

  • The FDA is currently studying five different treatment modalities. It contains antiviral drugs such as Remadecivir that prevent the virus from growing in the body. Such drugs are used in other diseases including HIV, herpes and hepatitis C.
  • Other treatments include immunomodulators (controlling immune response), antibody therapy (focus on antibody enhancement), cell therapy (cellular immunotherapy), and gene therapy (interfering with expression of genes and creating products).

How does remadecivir work against corona?

  • When the coronavirus enters the body, it releases genetic material. He grows using the body’s mechanism. When the patient is given Remedisivor, he dodges the virus and replicates the mechanism of the body. This does not give the virus an opportunity to grow and stops its growth.

WHO is not approving it? Why is he warning?

  • WHO Chief Scientist Soumya Swaminathan has told drug regulators all over the world that the drug has little or no benefit following the US-FDA approval of remadecivir. There is strong evidence for this. For this reason, do not be hasty in giving it approval.
  • In fact, the WHO had conducted the largest Solidarity Trials and had tested the effect of Remadecivir in Corona patients. It said that neither there was any improvement in health nor their days of hospitalization were reduced.
  • The WHO conducted the trial from 22 March to 4 October. In this, 11,266 patients were tested in 405 hospitals in 30 countries of 6 WHO regions. It found that remedisivir had no effect on corona deaths, periods of ventilation, and days of hospitalization.
  • FDA approval is based on the results of Gilead’s own trial. There were trials on 1062 people. Said that Remedisivir can reduce the recovery time by up to five days. It also reduces the risk of death in patients taking oxygen support.
  • The WHO has also made it clear that in two-three weeks it will clear the situation regarding Remedisvir. In fact, after FDA approval, he is thinking again on this treatment plan. A meeting is also called to assess Gilead Sciences’ claims next week.

What is the situation regarding Remadecivir in India?

  • Even though WHO has warned about Remedesvir, its emergency use is being hurriedly used in India. The situation is also bad about its demand and supply. Its deficiency is being taken seriously in many states.
  • It was said that after the US-FDA approval, its prices in India will increase. It does not look like this at the moment. The price of Remedisvir is going from Rs 2,900 to Rs 5,000 per dose. Initially its price went up to 25 thousand rupees. Black marketing was also started.
  • Cipla, Hetero, Dr. Reddy’s, Jubilant Lifesciences and Zydus Cadila received licenses to manufacture generic versions of RemdesiVir in May. It is currently available in Indian markets. Governments in some states have also included it in the Corona Treatment Plan.

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