WASHINGTON (WNN) – Drugmaker Merck said Friday that its experimental COVID-19 pill has cut hospitalizations and deaths among people recently infected with the coronavirus by half, and that it will soon be available to health workers in the US and around the world. Ask the authorities to authorize its use.
If approved, the drug would be the first pill shown to treat COVID-19, a potentially major advance in efforts to fight the pandemic.. All COVID-19 Treatments Now authorized in the US an IV or injection is required.
Merck and its partner Ridgeback Biotherapeutics said early results show that patients who received the drug, called mollupiravir, had the same rates of hospitalization and death within five days of COVID-19 symptoms as those patients. There were about half of those who had received the dummy pill. The study tracked 775 adults with mild to moderate COVID-19 who were considered at high risk for severe disease because of health problems such as obesity, diabetes or heart disease.
Of the patients taking molanupiravir, 7.3% were either hospitalized or died at the end of 30 days, compared with 14.1% of those taking the dummy pill. According to Merck, there were no deaths in the drug group after that time period, compared to eight deaths in the placebo group. The results were released by the company and have not been peer-reviewed by outside experts, the normal process for examining new medical research. Merck said it plans to present them at a future medical meeting.
An independent group of medical experts overseeing the trial recommended stopping it early because the interim results were so strong. This is typical when preliminary results show so clearly that the treatment is working that there is no need for further testing before applying for authorization. Company officials said they plan to submit the data for review by the Food and Drug Administration in the coming days. Once submissions are complete, the FDA could make a decision within weeks — and, if approved, the drug could soon hit the market.
“What I thought was what I might be able to do in this clinical trial,” said Dr. Dean Lee, vice president of Merck Research Laboratories. “It’s a significant clinical effect when you see a 50% reduction in hospitalizations or deaths.”
Side effects were reported by both groups in the Merck trial, but they were slightly more common among the group that received a dummy pill. The company did not specify the problems.
Patients take the tablet twice a day for five days to complete a course of treatment.
Results from an earlier study showed that the drug did not benefit patients who were already hospitalized with serious illness.
The US has approved remdesivir, an antiviral drug specifically for COVID-19, and allowed emergency use of three antibody therapies that help the immune system fight the virus. But all drugs have to be given by IV or injection into hospitals or medical clinics, and the latest surge of the Delta version has spurred supplies.
Health experts, including America’s top infectious disease expert Dr. Anthony Fauci, have long called for a convenient pill that patients can take when symptoms of COVID-19 first appear, just like the standard flu medicine. Tamiflu helps fight influenza. Such drugs are seen as the key to controlling future waves of infection and mitigating the impact of the pandemic.
Merck’s pill works by interfering with the ability of the coronavirus to copy its genetic code and reproduce itself. It has shown similar activity against other viruses.
The US government has committed to purchase 1.7 million doses of the drug if authorized by the FDA. Merck has said it can produce 10 million doses by the end of the year and has contracts with governments around the world. The company has not announced the prices.
Several other companies, including Pfizer and Roche, are studying similar drugs that could report results in the coming weeks and months.
Merck had planned to enroll more than 1,500 patients in its final phase trial before the independent board stopped it early. The results reported on Friday included patients enrolled in Latin America, Europe and Africa. Executives estimate that about 10% of the patients studied were from the US
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