Gilead’s Remdesivir, Approved by FDA as COVID-19 Treatment
Patients at least 12 years old and above with at least 40 kilograms of weight and require hospitalization. These COVID positive patient's characteristics were approved eligible by the U.S Food and Drug Association to be medicated or treated with antiviral drug Veklury or Remdisivir.
According to FDA Commissioner, Stephen Hahn, M.D., the agency is committed to expediting development and availability when it comes to the Treatment of COVID-19 patients in this unprecedented public health emergency.
Developed by Gilead Sciences, the said antiviral drug has been authorized for temporary use in approximately 50 countries worldwide, as COVID-19 Treatment.
According to the WHO or World Health Organization, as of October 22, there have been over 41 million confirmed cases of COVID-19 and over 1 million deaths reported.
Remdesivir is the only fully approved treatment in the US.
antiviral drug Remdesivir approved by the US FDA
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Approval
It is remembered that the FDA granted the drug an Emergency Use Authorization or EUA, but according to the agency, this approval does not involve the entire population covered by the issued EUA. According to Section 564 of the Federal Food, Drug & Cosmetic Act, EUAs do not remain in effect indefinitely, and they can consider whether a sponsor is seeking FDA Approval in evaluating its appropriateness.
However, in approval, section 505(c) of FD&C Act, states that FDA must take into account the drug's safety and effectiveness for its labeled use, and the benefits of the drugs outweigh the risks, labeling package inserted is appropriate, and the methods used in manufacturing the drug maintain is identity, strength, quality, and purity.
The three clinical trials were conducted by the National Institute of Allergy and Infectious Disease.
According to the US FDA, three randomized, controlled clinical trials that included mild to severe COVID-19 Patients as respondents were divided into two groups: 5-day Veklury treatment and 10-day Veklury Treatment. The results showed that COVID-19 symptoms improving were similar in recovery rates or mortality rates. It was the basis of the agency's analysis of data and their approval.
In an FDA news release, the agency said that important information about Veklury treating COVID-19 for its approved use is available in the prescribing information including the dosing instructions, potential side effects, and drug interactions.
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Effectiveness
It is remembered that Gilead Sciences earlier in the year said, their preliminary results of a coronavirus drug trial showed at least 50% of patients treated with a five-day dosage of Remdesivir was discharged from the hospital after two weeks.
But according to the study coordinated by WHO, Remdesivir shows "little or no effect" on death rates among hospitalized patients alongside Hydroxychloroquine, Lopinavir, and Interferon-beta 1a which was included in their study.
A study or final report named Remdesivir for the Treatment of COVID-19, published in New England Journal of Medicine stated their method of using the drug undergone series of tests in adults that has evidence of lower respiratory tract infection. Results showed that those who received Remdesivir had a median of 10 days of recovery time.
Dr. Anthony Fauci, the nation's leading infectious disease expert said earlier in the year that the drug would set a new standard of care and treatment for COVID-19 patients.
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Oct 25, 2020 08:00 PM EDT
