If cleared, Merck’s drug is the first pill shown to treat COVID-19 and is a potentially significant advance in efforts to combat the pandemic. All COVID-19 therapies currently approved in the United States require IV or injection.
According to Merck and its partner Ridgeback Biotherapeutics, early results showed that patients who received a drug called molnupiravir within 5 days of COVID-19 symptoms had about half the hospitalization and mortality rates of those who received the dummy pill. bottom. The study followed 775 adults with mild to moderate COVID-19 who are considered to be at high risk for severe illness due to health problems such as obesity, diabetes, and heart disease.
Among patients taking molnupiravir, 7.3% died 30 days after admission or 30 days, compared to 14.1% of patients taking dummy pills. According to Merck, there were no deaths in the drug group after that period, compared to eight deaths in the placebo group. Results have been published by the company and have not been peer reviewed. Merck said he plans to present them at future medical conferences.
An independent group of medical professionals monitoring the trial recommended that the trial be stopped early because the interim results were so strong. Company executives said they were in talks with the Food and Drug Administration and would submit the data for review in the coming days.
Dr. Dean Lee, Merck’s Vice President of Research, said: “If hospitalization or mortality is reduced by 50%, it is a substantial clinical effect.”
Side effects were reported by both groups in the Merck trial, but were slightly more common in the dummy pill-treated group. The company did not identify the problem.
Previous studies have shown that the drug did not benefit patients who were already hospitalized for serious illness.
The United States has approved one antiviral drug, remdesivir, specifically for COVID-19, allowing the emergency use of three antibody therapies to help the immune system fight the virus. However, all drugs had to be given by injection in IV or in hospitals and clinics, and the supply was expanded by the recent surge of delta mutants.
Health professionals, including Dr. Anthony Fauci, a top US infectious disease specialist, have long sought convenient pills that patients can take when COVID-19 symptoms first appear. This is just as the flu drug Tamiflu, decades ago, helps fight the flu. Such drugs are seen as the key to controlling the wave of future infections and reducing the effects of pandemics.
Merck tablets work by interfering with the enzyme that the coronavirus uses to copy its genetic code and replicate itself. It shows similar activity against other viruses.
The US government has promised to buy 1.7 million doses of the drug with FDA approval. Merck says it will be able to produce 10 million batches by the end of the year and has contracts with governments around the world. The company has not announced prices.
Several other companies, including Pfizer and Roche, are researching similar drugs that may report results in the coming weeks and months.
Merck planned to enroll more than 1,500 patients in late-stage trials before the Independent Commission discontinued early. Results reported on Friday included patients enrolled in Latin America, Europe, and Africa.Executives estimated that about 10% of the patients studied were from the United States
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What’s new in coronavirus: The first pill to treat COVID-19 looks promising, says New Jersey-based pharmaceutical company Merck
Source link What’s new in coronavirus: The first pill to treat COVID-19 looks promising, says New Jersey-based pharmaceutical company Merck