We must learn to pronounce the name of a new drug in the context of the pandemic of Covid-19: molnupiravir. It is the first antiviral in the world to have received the go-ahead from a drug regulatory agency.
This Thursday, it was approved by the United Kingdom and, immediately afterwards, the European Medicines Agency (EMA) declared that it was favorable to recommend to their member states the use. Everything indicates that before the end of the year it would obtain an even greater medical and scientific consensus.
As he could know Clarion From sources in the pharmaceutical industry, the local subsidiary of the MSD laboratory, which produces this new drug, is working with the ANMAT and the Ministry of Health so that Argentina can have access to this pill in the shortest possible time.
“Today is a historic day for our country, because the UK is now the first country in the world in approving an antiviral against Covid that can be taken at home, “British Health Minister Sajid Javid said in a statement.
The UK approved the drug for patients who have at least one risk factor (obesity, diabetes, hypertension and kidney failure), although each regulatory agency can decide whether to restrict it to that population or to extend it to those patients who do not have comorbidities.
From the laboratory they warned that the antiviral does not replace the vaccine, but rather complements it.
The clinical trial, which had 55 percent of volunteers in Latin America and of which Argentina was a part, demonstrated a 50 percent reduction in the risk of hospitalization. In addition, in the group that took the pill, none died and in the group that received placebo. there were 8 fatalities.
The EMA pointed out in the last hours that it seeks speed up the study that launched last week on this drug, in order to be able to authorize its commercialization. “We will try to speed up our evaluation to get authorization in the shortest time, “said Marco Cavaleri, head of EMA’s vaccination strategy.
For now there is no exact date for the antiviral to have a free pass in Europe. The US FDA is also expected to deliver its verdict shortly. These two instances would be key so that the authorization process in Argentina also acquires speed.
How does molnupiravir work? It is an antiviral that achieves camouflage itself as a false link of the Covid RNA chain and “misleads” the virus. “It produces what is called ‘error catastrophe’ and the virus then cannot copy itself. It is as if it were a photocopy that loses quality with each new copy. In this way, the viral load falls ”, he explained to Clarion Gabriela Bugarin, medical manager of MSD Argentina.
Although a version emerged on Thursday that our country could be a producer of a generic of this antiviral, Bugarin explained that “this possibility exists only for countries that the World Bank considers to be of low and medium resources, a list in which Argentina is missing”.
The pill should be administered within the first five days of the onset of symptoms. Photo: Orlando Pelichotti
As MSD does not have national drug production, the only chance of having molnupiravir would be import. However, these are the issues that must be finalized once the national health authority approves the drug.
Bugarin said that the laboratory produced so far, in different production plants around the world, 10 million treatments. The drug must be administered within the first five days of symptom onset and the trial found that on the fifth day treatment patients did not have infectious virus. The dosage is 800 milligrams every 12 hours (each pill is 200 mg).
The expert noticed something important: “Molnupiravir does not replace vaccines, but it is something complementary. One of the things to highlight is that it is administered orally and outpatiently and has a profile of low risk of interaction against medications that patients may be taking ”. A key piece of information, especially if the target is people with comorbidities.
The trial in which Argentina participated was carried out with unvaccinated volunteers, because it started when the immunization campaigns were just beginning. Now Argentina is participating in a “Post-exposure prophylaxis study, which consists of administering molnupiravir to the partners of people whose tests have been positive, to evaluate whether the antiviral can also avoid contagion”.
Regarding the cost of the medicine, the laboratory explained that it will be adapted to the economic and health reality of each countrys, so it could have different prices depending on the case. Industry sources consulted stressed that possible ANMAT approval could be accelerated when the EMA or FDA authorizes the pill.
Clarion He also consulted sources from the Ministry of Health to find out what are the possibilities that Argentines have access to this drug in the short term. The response was cautious: “This is an antiviral that for now has only been approved in the UK. We are evaluating it. When we have information we will communicate it ”, they said.