Last Friday, the WHO published in The British Medical Journal an advice to doctors, which repudiates the US FDA’s approval of remdesivir as COVID-19 treatment.
Gilead, the American biotechnology company that developed remdesivir, which it manufactures under the brand name Veklury, immediately published a statement opposing the medical advice published by the World Health Organization (WHO).
The biotech company insists that remdesivir is regarded as a customary treatment in aiding patients battle against the coronavirus disease. Gilead cited guidelines from various reliable organizations worldwide as confirmations; including those published by the Health and Infectious Diseases Societies of America, Germany, Japan and the UK.
Why is WHO Against the Use of Remdesivir as COVID-19 Treatment?
According to a panel of specialists comprising the WHO Guideline Development Group (GDG), currently, there is still not sufficient proof that the remdesivir drug is capable of increasing the survival chances of patients infected with COVIS-19, and much less, capable of speeding up recovery time. The WHO’s statement created a huge disparity between the two country’s regulatory guidance on the acceptability of medications used as coronavirus treatments.
The panel of specialists are experts coming from all around the globe, who based their recent findings on comparisons made over the different effects yielded by various COVID-19 drug treatments. Additionally, the panel of international experts also provided evidence from four random international clinical trials that encompass over 7,000 hospitalized patients infected by the virus.
With the data they have collected, the expert panel of WHO GDG concluded that the antiviral drug remdesivir has no effect as far as reducing the mortality of the patients are concerned. Additionally the GDG also discovered that remdesivir has no meaningful significance in determining a patient’s need for mechanical ventilation or in determining the period for clinical improvement.
About FDA’s Approval in the Use of Remdesivir as Coronavirus Treatment
A month ago, the US Food and Drug Administration approved the use of the Veklury antiviral drug, the branded name of the generic remdesivir medication for the treatment of Covid-19 infected adults and children over the age of 12 who weigh at least 40 kilograms or 88 pounds. Actually, the Veklury is the very first coronavirus treatment that received approval from the US FDA, but was given under a condition that the drug can only be used by healthcare facilities or hospitals that are capable of giving acute care to COVID-19 patients
As it turned out, the US FDA’s approval of the remdesivir is not applicable to the overall population as its initial approval was made under the conditions of Emergency Use Authorization (EUA). The approval was later revised in order to continuously give access to children covered by the EUA.
The administration modified the authorization of remdesivir use by including patients below 12 years old but only if the child weighs at least 3.5 to 40 kilograms. Apparently, the approval of remdesivir as a coronavirus treatment under the Emergency Use Authorization (EUA) still requires continuation of ongoing clinical trials in order to evaluate the safety and efficiency levels of the drug, particularly for the pediatric population.