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The drug maker Merck said its experimental COVID-19 pill has halved the number of hospitalizations and deaths of people who have recently contracted the coronavirus, and will soon require health officials in the United States and around the world to authorize its use.
If approved, the drug will become the first pill to treat COVID-19, which may be an important step forward in global efforts to control the pandemic. All COVID-19 treatments now authorized in the United States require intravenous or injection.
The company’s chief executive officer and president Robert Davis said in a statement on Friday: “With these compelling results, we are optimistic that as part of the global effort to fight the pandemic, Monopilav Can become an important drug.”
In contrast, a pill that can be taken at home can keep many patients away from the hospital, reducing the workload of stressful healthcare professionals.
It can also help curb outbreaks in low-income countries that do not have access to more expensive infusion therapies.
Merck and its partner Ridgeback Biotherapeutics said that early results showed that within 5 days of the onset of COVID-19 symptoms, the hospitalization rate and mortality rate of patients receiving the drug called molnupiravir was about half of those receiving counterfeit drugs.
The study tracked 775 adults with mild to moderate COVID-19 who were considered to be at higher risk of serious illness due to health problems such as obesity, diabetes or heart disease. The results are not peer reviewed by external experts, which is a common procedure for reviewing new medical research.
All COVID-19 treatments now authorized in the U.S. require IV or injection [File: Matt Rourke/AP Photo]Among patients taking monelavir, 7.3% were hospitalized or died at the end of 30 days, compared with 14.1% of patients taking counterfeit drugs.
According to Merck, there were no deaths in the drug group after this period of time, while 8 people in the placebo group died.
The panel of independent medical experts monitoring the trial recommends stopping the trial as soon as possible because the interim results are very good.
This is typical when the early results are so clear that the treatment is effective that no further testing is required before applying for authorization. Company executives said they plan to submit the data to the Food and Drug Administration for review in the next few days.
After the submission is complete, the FDA can make a decision within a few weeks-if approved, the drug may be on the market soon. Merck has only studied its drugs in people who have not been vaccinated.
But the FDA regulatory agency may consider authorizing it to be used more widely in vaccinated patients with COVID-19 symptoms.
Dr. Dean Li, vice president of Merck Research Laboratories, said: “This is beyond what I think the drug might play in this clinical trial.” “When you see a 50% reduction in hospitalizations or deaths, this is a major clinical trial. Influence.”
‘Very inspiring’
Peter Hobby, professor of emerging infectious diseases at Oxford University, called the interim results “very encouraging.”
“A safe, affordable and effective oral antiviral drug will be a huge advance in the fight against COVID,” he said.
Oksana Pyzik, a global health consultant and lecturer at University College London, told Al Jazeera that Merck pills are “more convenient than many other types of treatments, including monoclonal antibodies, which are more expensive and more complicated.”
She added: “Therefore, it is time for us to introduce an easy-to-carry tablet at home in our various drug kits that can help prevent and fight the coronavirus.”
However, experts also reminded them that they want to see the complete basic data, and emphasized that if it is finally approved, the drug should be supplemented with a highly effective vaccine instead of being taken.
The patient took eight pills a day for five days. In the Merck trial, side effects were reported in both groups, but in the group that received counterfeit drugs, side effects were slightly more common. The company did not specify the problem.
Early research results indicate that the drug is not beneficial to patients who have been hospitalized for serious illnesses.
The United States has approved an antiviral drug Remdesivir specifically for COVID-19 and allows emergency use of three antibody therapies that help the immune system fight the virus.
But all drugs must be administered intravenously or by injection in hospitals or medical clinics, and the recent surge in Delta variants has caused tight supply.
Health experts, including Anthony Fauci, the top infectious disease expert in the United States, have long called for the development of a convenient pill that patients can take when they first show symptoms of COVID-19, just like standard flu drugs. Tamiflu helps fight the flu the same.
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