Newsletter: The path to recovery
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Merck said U.S. regulators would be asked to approve the first antiviral pill for the treatment of Covid-1 treat, when late-stage clinical trials show the drug halved the risk of hospitalization or death.
If the U.S. Food and Drug Administration approves the drug Malnupirvi, it would be the first treatment of its kind সম্প্রতি a double daily pill prescribed for five days for patients with recently covid.
The U.S. pharmaceuticals company said Friday it closed a third-stage clinical trial after an interim analysis showed that 7.3 percent of patients died or were hospitalized with the drug, where 14.1 percent received a placebo.
The decision to discontinue the study was made following the recommendation of an independent committee of scientists who observed the study and in consultation with the FDA.
Interim analysis of data from 775 patients showed that none of the participants taking Molnupirvi died within the first 29 days of the study, vs. eight who received placebo, Merck said.
Mark said the U.S. would apply for emergency use approval for the drug within the next two weeks and several other countries would seek green light.
Mark said the drug has shown “consistent efficacy” in a number of coronavirus forms, including highly contagious delta strains that have created new waves of covid case in several countries.
An FDA approval would pave the way for general practitioners to begin prescribing pills for “outpatient patients” who have not yet been hospitalized.
“It’s quite remarkable to be the first oral antiviral on the outside to show benefits,” said Nick Cartesonis, senior vice-president of Mark’s Clinical Research. “This is clearly an important factor in the evolution of our fight against Covid-1.”
Merck said the 10th course of treatment is expected to be completed by the end of the year. The U.S. government recently signed an agreement to procure about 1.m million courses in medicine, and the pharma company has agreements with several other countries.
Mark Rizbak is creating Antiviral Therapies in partnership with Biotherapeutics, a small Miami-based biotech company run by a wife and husband team. Companies are in competition with Pfizer to create a pill that can be prescribed immediately after infection with the intent to prevent serious disease.
Health experts predict that such drugs could help accelerate the end of an epidemic that affects more than 7.m million people worldwide.
To date, the only treatment approved for covid in the United States is monoclonal antibodies developed by Regeneron, Eli Lilly, and GlaxoSmithKline, usually given intravenously.
Within the first five days of showing symptoms, Molnupirvir was studied in patients tested positive for covid, who had at least one “risk factor” such as old age, obesity or diabetes which meant they could become seriously ill.
However, the relatively short duration can be a challenge for the healthcare system as many patients do not get a definitive diagnosis of covid until the five-day window is over.
Previous tests of Malnupirvir among hospitalized patients were discontinued after hospital results.