Remdesivir, here is the viral war between the American FDA and the WHO
Because the FDA has approved the Gilead company's Remdesivir for the anti Covid treatment, despite the WHO's rejection. All the details
Green light from the Food and Drug Administration to Remdesivir as a treatment for Covid-19. Despite the slowdown of the World Health Organization on the effectiveness of the drug in reducing mortality, the US government body lists the drug among those recommended.
All the details.
THE FDA DECISION
Let's start with the latest news. "Veklury (the trade name of the drug Remdesivir, ed ) is the first treatment for Covid-19 to receive FDA approval," said the US authority.
It is recommended for use "in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (88 lbs) for the treatment of Covid-19 requiring hospitalization".
THE MERITS OF THE DRUG
According to data analyzed by the regulatory agency, the antiviral developed by the American Gilead for the treatment of Ebola and used in an off-label form for the treatment of the coronavirus reduces recovery times by an average of 5 days.
"Today's approval is supported by data from multiple clinical trials that the agency has rigorously evaluated and represents an important scientific milestone in the Covid-19 pandemic," explained FDA commissioner Stephen Hahn.
THREE DIFFERENT CLINICAL STUDIES
In particular, the decision was made on the basis of three different clinical trials "randomized and controlled that included hospitalized patients with mild to severe Covid-19", explains the authority.
One of the studies showed that "the median time to recovery from Covid-19 was 10 days for the Veklury group compared to 15 days for the placebo group".
WHO HAS TAKEN THE REMDESIVIR
The FDA's decision comes despite the rejection by the WHO . Remdesivir, like hydroxychloroquine, lopinavir / ritonavir combination and interferon-based regimens – explains the Organization – is ineffective in the treatment of Covid-19. The four therapies, specifies in a statement, "seem to have little or no effect on mortality at 28 days or on the hospital course of Covid-19 among hospitalized patients".
THE STUDY WHO WAS BASED ON
WHO among its conclusions from the United Nations health agency's Solidarity Trial conducted on 11,266 adults in 30 countries. Of these 2750 patients received remdesivir, while 4088 received placebo.
The trial “investigated the effects of these treatments on overall mortality, on the initiation of intubation and on the length of hospitalization. Other uses of therapies, for example on the treatment of patients in communities or for prevention, will be examined in different trials ”, according to the WHO, which with data in hand rejects the Gilead antiviral.
THE EU ALSO APPROVED REMDESIVIR
Even Europe, already several weeks ago, approved Remdesivir as a drug for the treatment of Covid. Ema made its decision based on data from the NIAID-ACTT-1 study, sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), as well as supporting data from other remdesivir studies. The study evaluated the effectiveness of a scheduled 10-day remdesivir course in more than 1,000 hospitalized patients with Covid-19.
DOUBTS OF FRANCE
However, after the approval of the EMA, France had expressed some doubts. Has, the French drug agency, wrote that "the actual benefit is considered low in light of current preliminary data showing an overall 4-day reduction in the patient's clinical recovery time (11 days instead of 15) compared to placebo and, in addition to supportive care, this is of dubious clinical relevance ". The drug, added the Authority, "does not show an overall effect on mortality at 14 days in this phase, with a possible effect only suggested in patients requiring low-flow oxygen therapy".
REMDESIVIR
Remdesivir is a nucleotide prodrug that is metabolized intracellularly, as stated in the protocol drawn up by the manufacturer, Gilead Sciences, an American biotechnology company that researches, develops and markets drugs.
The drug was developed as a treatment for Ebola virus disease and Marburg virus infections. Several studies have shown its effectiveness as an antiviral against single-stranded RNA viruses such as respiratory syncytial virus, Junin virus, Lassa fever virus, Nipah virus, Hendra virus, and Coronavirus (including MERS and SARS viruses).
In Europe the drug is marketed under the name of Veklury.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/remdesivir-ecco-la-guerra-virale-tra-lamericana-fda-e-loms/ on Sat, 24 Oct 2020 09:20:49 +0000.