Newsletter: The road to recovery
Expert coverage on how business and the economy are recovering, following the pandemic. Delivered 3 times a week.
Merck said it would ask U.S. regulators to give initial approval antiviral pill to treat Covid-19 after a late-stage clinical trial has shown that the drug halves the risk of hospitalization or death.
If the U.S. Food and Drug Administration approves the drug, molnupiravir, it would be the first treatment of its kind – a pill prescribed twice a day for patients recently diagnosed with Covid.
The U.S. pharmaceutical company said Friday that it discontinued the Phase 3 clinical trial early after an interim analysis showed that 7.3 percent of patients who suffered, died or were hospitalized, compared to 14.1 percent of those who received a placebo.
The decision to stop the study was made following a recommendation from an independent committee of scientists monitoring the trial and after consultations with the FDA.
The interim analysis of data from 775 patients showed that none of the participants who received molnupiravir died during the first 29 days of the study, compared to eight who received a placebo, Merck said.
Merck said it would apply for emergency drug clearance in the U.S. within the next two weeks and seek a green light in several other countries.
The drug has shown “consistent efficacy” in several coronavirus variants, including the highly transmissible Delta strain that has led to a new wave of Covid cases in several countries, Merck said.
An FDA authorization will pave the way for general practitioners to prescribe the pill to recently diagnosed patients who have not yet been admitted to the hospital.
“Being the first oral antiviral drug in the outpatient setting that shows a benefit is quite remarkable,” said Nick Kartsonis, senior vice president of clinical research at Merck. “This is clearly an important point in the development of our fight against Covid-19.”
Merck said it is expected to produce 10 million treatment jobs by the end of the year. The US government recently signed an agreement to purchase approximately 1.7 million doses of medicine, and the pharmaceutical company also has agreements with several other countries.
Merck is developing the antiviral treatment in partnership with Ridgeback Biotherapeutics, a small biotechnology company in Miami run by a women-and-man team. The companies are in a race with Pfizer to develop a pill that can be prescribed shortly after infection with the aim of preventing serious diseases.
Health experts have predicted that such a remedy could be an important tool to help hasten the end of a pandemic that has cost more than 4.7 million lives worldwide.
So far, the only treatments approved for Covid in the US monoclonal antibodies developed by Regeneron, Eli Lilly and GlaxoSmithKline, which are typically administered via intravenous infusions.
Molnupiravir has been studied in patients who tested positive for Covid within the first five days after their symptoms, who also had at least one ‘risk factor’, such as old age, obesity or diabetes, which means they could become seriously ill.
However, the relatively short time frame can be a challenge for healthcare systems because many patients only receive a confirmed diagnosis of Covid long after the five-day window.
An earlier trial of molnupiravir in hospitalized patients was discontinued after disappointing results.