NEW YORK. Merck will ask “as soon as possible” theemergency authorization in the United States for the first anti-Covid pill. “Molnupiravir halves the risk of hospitalization and death in patients with Covid-19,” says the US pharmaceutical company, which has announced that it will ask the US Food and Drugs Administration for the drug to be authorized.
Merck has made it known that it has completed phase 3 of a clinical study, after “an interim analysis had shown that 7.3% of the patients who received the drug had died, while among those who received a placebo the death rate was 14.1%».
A’data analysis on 775 patientsMerck said, showed that “none of the subjects who received molnupiravir died during the first 29 days of the study,” compared with 8 deaths among those who took a placebo.
If the drug were approved, it would become the first of its kind. The pill must be taken twice a day for five days by those who have recently been diagnosed with Covid-19. Merck said it will apply for emergency clearance in the US within the next two weeks and then apply for it in other countries.
The drug, the company said, has shown “consistent efficacy” against numerous variants of the new coronavirus, including the Delta variant. All patients involved in the study had at least one risk factor, such as diabetes, obesity, or advanced age.
“As the first oral antiviral to show benefit in newly diagnosed patients, it is quite remarkable,” he commented Nick Kartsonis, Merck’s vice president of clinical research, “is clearly a major turning point in the evolution of our fight against Covid-19.”
Merck expects to produce 10 million treatment cycles by the end of the year. The US government has signed an agreement to obtain approximately 1.7 million. The antiviral was produced in partnership with Ridgeback Biotherapeutics, a family-owned Miami company. So far the only treatments available to cure Covid-19 have been monoclonal antibodies produced by Regeneron, Eli Lilly and GlaxoSmithKline, which are administered intravenously.
The advent of an antiviral pill is considered by experts to be a milestone in the fight to end the pandemic. The need for the drug to provide for Covid-19 to be newly diagnosed to be effective nonetheless poses a challenge to health authorities. A previous test carried out on hospitalized patients had in fact had disappointing results.