The Federal Commission for the Protection against Sanitary Risks (Cofepris) has authorized this Friday the first pill against covid-19 in Mexico. The drug molnupiravir from the pharmaceutical group Merck will be prescribed to patients with mild to moderate coronavirus who have a high risk of complication, as reported by the country’s health authorization agency. The treatment is not a substitute for vaccination, nor should it be used without a medical indication, the Government has warned.
The head of Cofepris, Alejandro Svarch Pérez, has highlighted that Mexico is one of the first countries to authorize the pill against covid-19. “This approval is issued in record time, since the health regulatory agencies in the world have scientific evidence that allows us to evaluate this oral therapeutic option as safe and effective that will reduce hospitalizations for covid-19,” he said. This type of treatment is already authorized in the United States and Japan, and is being analyzed in other countries such as Canada, Australia and Switzerland.
The drug approval process began two weeks ago, as detailed in a statement the regulatory agency. “Specialized personnel from the Health Authorization Commission evaluated the evidence presented by the company Merck Sharp & Dohme BV, certifying compliance with the necessary requirements to guarantee quality, safety and efficacy of molnupiravir”, he says. The authorization was issued based on data from “MOVe-OUT, a randomized, double-blind, placebo-controlled clinical trial that studies the effectiveness of the drug for the treatment of out-of-hospital patients with mild to moderate and high risk covid-19 of becoming seriously ill and being hospitalized ”, he argues.
The molnupiravir pill works by introducing errors in the genetic code of the virus, preventing it from replicating in the body, explains the dependence. “It is an oral medication delivered through capsules for five days,” he says. According to the Merck Research Laboratories clinical trial published in New England Journal of Medicine, oral treatment against COVID-19 in early stages reduces hospitalizations and deaths in people with high-risk diseases by almost 30%.
Cofepris has determined that the drug will be used for adults with mild to moderate coronavirus who have at least one risk factor for developing severe COVID-19. Patients should not require supplemental oxygen and are required to have a positive virus diagnostic test. The drug will also be used for those for whom authorized COVID-19 alternative treatment options are not accessible or clinically appropriate. His medical prescription will be required to “avoid the misuse of this drug, self-medication and irregular sale,” he adds.
President Andrés Manuel López Obrador had advanced since this morning the approval of the pill. The president has indicated that the drug will mainly be applied in public hospitals to make it accessible to all people. He has also announced that next week there will be a review of Paxlovid, the oral antiviral from the pharmaceutical company Pfizer. “Let it be known that there are two (drugs) and they act fast, not only is the time of discomfort less, but also less time of the disease, of contagion, it takes less time to leave,” he declared.
Mexico accumulates more than 4 million infections by covid-19 and has exceeded 300,000 deaths this Friday. The daily numbers of infections have grown by almost 875% since Monday before the advance of the omicron variant. However, deaths have not increased at the same rate. The Government highlights that hospital occupancy is 19% and insists that the new variant of coronavirus “does not have the level of danger” of others.
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Eddie is an Australian news reporter with over 9 years in the industry and has published on Forbes and tech crunch.