Veklury-Remdesivir of Gilead, here are the moves of Brussels
The European Commission has signed a joint procurement framework agreement with the pharmaceutical company Gilead for the supply of Veklury, the trade name of R emdesivir , up to 500,000 treatment cycles and which also includes the possibility of increasing the supply.
Is remdesivir, the first drug approved for the treatment of Covid-19 and administered, among others to Donald Trump and Silvio Berlusconi, starting to run out in Italy and in the rest of Europe?
The drug, which has the trade name Veklury, has proved capable of reducing the average sick days from 15 to 11, but does not convince the French drug agency. Meanwhile, Brussels signs a contract for 500,000 treatment cycles with the manufacturer Gilead.
Let's go step by step.
THE DOSES OF REMDESIVIR ARE DOWN
But is it hard to find Remdesivir in Europe and Italy?
In Italy, as Nicola Magrini, general manager of AIFA, the Italian Medicines Agency explains, "the need exceeds availability". “The risk of shortage is high”, Magrini adds , specifying that “the increase in demand risks leading to the exhaustion of stocks over the weekend. Collaboration mechanisms with other European countries are active to prevent this from happening ”.
Last night on Rete 4 Professor Marco Bassetti of the San Martino Hospital in Genoa praised AIFA for being able to stock up on the drug and claimed that at the moment it has not found any shortages of the drug.
THE USE OF THE DRUG IN ITALY
Currently, about 100 patients a day use the drug in our country, who are hospitalized and have a moderate need for oxygen, according to data from the Republic.
“To obtain the drug they must fill out a request for each patient, to be sent directly to AIFA between 10 and 12 every day. The Italian Medicines Agency then authorizes the dispatch of the vials from the depots, which are one in each region ”, specifies the newspaper. And to date, all requests have been met.
WHO SUFFERS BEYOND ITALY
Doses are also scarce in Great Britain, which will ration doses, and in Spain. In Holland, the anti Covid drug is practically finished, while Hungary, in agreement with Gilead , is trying to start a generic, homemade reproduction.
USA HAVE PURCHASED DOSES
The fact that the Veklury is in short supply is not surprising. The US, in fact, bought all the production of Gilead, until 30 September. And now that September is over, it is still hard to find the medicine.
A FEW VIALS COMING
A few vials, however, should arrive within a few days. In fact, Europe is about to distribute a batch of 20,000 ampoules (enough for 3,300 patients) among the various countries.
THE NEW EU-GILEAD AGREEMENT
And not only. In the past few hours, the European Commission has secured the joint award of up to 500,000 treatment cycles (with the option of increasing doses). The agreement was signed alongside the Commission by the United Kingdom, Albania, the Republic of North Macedonia, Montenegro, Serbia, Kosovo and Bosnia and Herzegovina.
In practice, all signatory countries will be able to place orders to directly purchase Veklury, the trade name of R emdesivir
DOUBTS OF FRANCE
Meanwhile, the first serious doubts about the drug arrive from France. According to the Has, the French drug agency , "the actual benefit is considered low in light of current preliminary data showing an overall reduction of 4 days in the patient's clinical recovery time (11 days instead of 15) compared to to placebo and, in addition to supportive care, this 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”.
THE 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).
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/innovazione/veklury-remdesivir-di-gilead-ecco-le-mosse-di-bruxelles/ on Fri, 09 Oct 2020 05:10:17 +0000.