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If approved by drug control agencies, it will be the first pill to treat COVID-19, and the arsenal of weapons that already includes vaccines will be supplemented with a completely new and easy-to-use tool.
“I can say that we will definitely consider launching more experience on this drug in the coming days,” Marco Cavaleri, head of vaccine strategy at the European Medicines Agency (EVA), told reporters. According to Cavaleri, the Amsterdam-based agency is aware of “the highest results reported by the company.”
The US pharmaceutical company Merck has indicated that it will soon contact US and global health officials to obtain permission to use the drug. After this appeal, the US Food and Drug Administration can make a decision in a few weeks, and if the drug is approved, it will be able to reach patients quickly.
All other COVID-19 approved products in the United States are currently administered intravenously or by injection. Pills that can be taken at home would ease the burden on hospitals and curb outbreaks of infection in the poorest and most remote corners of the world that do not have access to more expensive infusion therapy.
“It would allow us to cure many more people much faster and, we think, much cheaper,” said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University who was not involved in the study.
According to Merck and its partner Ridgeback Biotherapeutics, early results showed that among patients who took molnupiravir within the first five days of symptoms, hospitalization and mortality rates were cut in half compared to the placebo group.
The study examined 775 adults with mild to moderate COVID-19, but who were at risk for health problems such as obesity, diabetes, or heart disease. These results have not yet been reviewed by independent experts, although this is the usual procedure for any new medical examination.
Of the patients taking molnupiravir, 7.3% were hospitalized or died within 30 days. In the placebo group, meanwhile, 14.1 percent were patients. After a 30-day period, deaths were no longer recorded among people taking the new drug, although eight more people died in the placebo group, Merck noted.
The results were so compelling that a group of independent medical experts who observed the study recommended that it be terminated prematurely.
Company executives have indicated that they plan to send this data to the Food and Drug Administration in the coming days.
However, even as knowledge about a potentially effective new drug spreads, experts underscore the importance of vaccines in controlling a pandemic, as they help prevent the spread of the virus and protect those still severely infected from the disease. disease.
White House coronavirus coordinator Jeff Zients noted that vaccination will remain the government’s main strategy to control the pandemic. “We want to protect ourselves from infection, not just treat it when we get it,” he said.
Dr. Anthony Fauci, the US government’s top adviser on infectious diseases, described Merck’s results as “very good news.”
Merck only tested its drug on people who had not been vaccinated. However, Food and Drug Administration officials may allow the use of this drug in vaccinated patients experiencing COVID-19 symptoms.
Andrew Pekosz of Johns Hopkins University predicted that eventually vaccines and antiviral drugs would work together to protect against the worst effects of COVID-19.
“This drug should not be viewed as a substitute for vaccines; the two measures should be viewed as two strategies that can be used together to significantly reduce severe cases,” said virologist Pekosz.
Patients must take four molnupiravir pills twice a day for five days in a row. In the Merck study, side effects were reported in both groups, but they were slightly more common in the placebo group. What is this through the problem, the pharmaceutical company did not detail.
Previous studies have shown that this drug has not helped patients who have already been treated in hospital for severe forms of the disease. This is no surprise, since antiviral drugs are most effective when the virus is not yet embedded in the body.
The United States has approved an antiviral drug for COVID-19, remdesivir, and has approved three antibody therapies to help the immune system fight the virus. However, all of these drugs are expensive and can only be given or infused intravenously in hospitals or clinics. Not only that, due to the outbreak of the latest delta variant, their stocks are rapidly running out.
© Zuma Press / Scanpix
Studies have shown that antibody preparations for high-risk patients reduce hospitalizations and deaths by approximately 70 percent. – about 20% more than Merck pills. However, experts caution against comparing these drugs, as the Merck data is only preliminary.
Health experts, including Fauci, have long called for the development of convenient pills that patients can take as soon as the first symptoms of COVID-19 appear, similar to some drugs that help cure the flu faster.
As with other antiviral drugs, Merck pills interfere with the virus’s ability to copy its genetic code, preventing it from multiplying.
The United States government has promised to buy enough pills to cure 1.7 million. persons, subject to approval by the Food and Drug Administration. Merck says it could produce 10 million pills by the end of the year. patients and already have contracts with governments around the world. The company has not yet announced the price of this drug.
Several other drug companies, including Pfizer and Roche, are investigating similar drugs. They can publish their results in the next few weeks or months.
Until the independent board prematurely suspended the study, Merck intended to include more than 1,500 patients in its late-stage studies. Results reported Friday included patients in Latin America, Europe and Africa. About 10 percent. the patients observed were from the United States.
This tablet can change the fate of the drug manufacturer.
Merck & Co. did not present itself as one of the main players in the COVID-19 epic. The company twice tried unsuccessfully to develop a vaccine and gave up the drug, which it bought for $ 425 million. a deal worth a dollar a few months ago. The COVID-19 tablet he developed could hold the key to a turning point in this story, writes Bloomberg.
Merck’s Molnupiravir, which it is developing in collaboration with the private company Ridgeback Biotherapeutics LP, has cut the risk of hospitalization or death in half, as demonstrated by late-stage clinical trials. If successful, molnupiravir would be the first antiviral tablet on the market specifically designed to treat COVID-19.
Other important medications available must be administered in a hospital or infusion center, so they are generally not available to everyone except the most seriously ill patients.
The market reacted to the following results: Merck shares rose 8.4 percent to $ 81.40 a share, the largest increase in five years. Umer Raffat, an analyst at investment banking firm Evercore, questioned whether this could be a “turning point in the fight against COVID,” saying: “I don’t like hyperbolization, but the data is really that good.”
Even before the data was released, Mara Goldstein, an analyst at Mizuho Securities Co., said that molnupiravir could be a drug worth between $ 1 billion and $ 10 billion. Depending on how well it works and what side effects it causes.
The Molnupiravir story began long before Merck’s involvement. The chemical compound on which it is based has been known for decades. It works by interfering with the replication of the virus, thus preventing a serious disease condition.
Molnupiravir does not stop the virus from making copies, but instead introduces errors in the virus’s RNA, which replicates until the virus stops working.
When Ridgeback got involved in the process, an Emory University researcher was researching a flu drug, initially in the hope that the drug would be effective in fighting the Ebola virus. In March 2020, as the quarantine was just beginning in the United States, Ridgeback announced its deal for Molnupiravir. Two months later, Merck announced a deal with Ridgeback.
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