Remdesivir: joys and sorrows for Gilead
The doubts of the French drug authority on the use of Remdesivir, produced by the American company Gilead and approved by the EMA in the treatment by Covid. All the latest news
Remdesivir, the first drug approved for Covid-19 , may not be as effective. Doubts about the drug (known by the trade name, in Europe, of Veklury) come from France, where the Has, the national drug authority, is asking for a review of the evaluations.
Let's go step by step.
REMDESIVIR: THE OK FROM EUROPE
Let's start with what Europe had said. In June, the European Medicines Agency (EMA) announced that the Committee for Medicinal Products for Human Use (CHMP) recommended the use of the drug Remdesivir in adults and adolescents over 12 years old with coronovirus and in need of oxygen. additional.
THE AMERICAN STUDIO
The go-ahead to use the drug in anti Covid 19 treatment came on the basis of data from the NIAID-ACTT-1 study , sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), as well as supporting data from others studies on Remdesivir.
The study evaluated the efficacy of a scheduled 10-day Remdesivir course in over 1,000 hospitalized patients with Covid-19.
THE FRENCH DOUBTS
But some doubts about the study come from France. According to what the Has writes, in fact, "the actual benefit is considered low in light of the current preliminary data showing an overall reduction of 4 days in the patient's clinical recovery time (11 days instead of 15) compared to placebo and, beyond to supportive care, this which is of dubious clinical relevance ".
The drug, writes 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".
HAS: MUST NOT BE REFUNDED BY THE STATE
And this is why the Authority believes that "access to reimbursement is not justified for patients hospitalized for Covid-19 with pneumonia who need high-flow oxygen therapy, or oxygen therapy during non-invasive or invasive assisted ventilation or extracorporeal membrane oxygen therapy ”.
REFUND JUSTIFIED ONLY IN CERTAIN CASES
The reimbursement is justifiable "only in a population lower than that of the AG, or only in patients aged 12 years or older and weighing 40 kg or more", who have "pneumonia requiring low flow oxygen therapy" .
THE MOVES OF GILEAD
The Authority's declarations immediately prompted the manufacturer Gilead to withdraw the reimbursement request, effectively starting a dispute with France.
WHAT THE HAS REQUESTS
The Authority asks for a re-evaluation of the drug based on the 28-day mortality data of the American study "no later than October 2020 in a context of rapidly evolving therapeutic strategies".
THE USE OF THE DRUG IN ITALY
In Italy, Remdesivir is still used compassionately, therefore free of charge by the company.
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 demonstrated 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/innovazione/remdesivir-gioie-e-dolori-per-gilead/ on Mon, 21 Sep 2020 14:20:54 +0000.