Gilead Sciences México SRL de CV, entered the health registration application for the drug with the generic name remdesivir. Cofepris reported on the authorization for emergency use of the input on March 12, 2021.
“The drug received the opinion of the experts with the therapeutic indication for adult and pediatric patients (from 12 years with a minimum weight of 40 kg), who have less than seven days of COVID-19 symptoms and require hospitalization.
Whats Next?
According to the authorities, the next step consists of submitting files by each pharmacist. Which will be ruled by expert personnel of the Sanitary Authorization Commission.
About Remdesivir
Remdesivir is an intravenous nucleotide prodrug of an adenosine analog. Remdesivir binds to RNA-dependent viral RNA polymerase and inhibits viral replication by premature termination of RNA transcription.
The safety and efficacy of remdesivir with corticosteroid combination therapy have not been rigorously studied in clinical trials. However, there are theoretical reasons why combination therapy may be beneficial in some severe COVID-19 patients.
Follow-up and adverse effects
Remdesivir can cause gastrointestinal symptoms (eg, Nausea), elevated transaminase levels. As well as increased prothrombin time (without changes in the international normalized index) and hypersensitivity reactions.
Prothrombin time and liver function tests should be performed in all patients prior to remdesivir administration and during treatment as clinically indicated.
Remdesivir may need to be discontinued if alanine transaminase (ALT) levels rise to> 10 times the upper limit of normal and should be discontinued if an increase in ALT level and signs or symptoms of inflammation are observed. liver.
What do the professionals say?
“Remdesivir decreases the recovery time from 15 days to 11 days, which is certainly not overwhelming. It’s not a miracle cure, but four fewer days of illness is significant for patients and if it translates into shorter hospital stays, it would make a big difference in terms of how well our healthcare system can deal with COVID-19. ”. Patrick Jackson, assistant professor in the Division of Infectious Diseases and International Health at the University of Virginia, USA.
What the WHO says about the drug …
The World Health Organization (WHO) issued a conditional recommendation in November last year, suggesting not to use remdesivir in hospitalized patients, regardless of the severity of the disease, as there is currently no convincing evidence that the drug improves survival and other outcomes in these patients.
The conditional recommendation made by the WHO is part of the evolutionary guidelines on the clinical management of COVID-19 prepared by an international group of 28 experts in clinical care, four patient-associates and an ethicist.
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