Merck’s COVID-19 antiviral receives approval in the United States for its home antiviral medication. The US approved Merck’s COVID-19 antiviral tablet for select high-risk adult patients on Thursday, a day after approving a similar but more effective medication.
The US Food and Medicine Administration (FDA) stated that Merck’s drug, which is designed to induce faults into the virus’s genetic coding, might be used in situations where existing approved therapies are unavailable or clinically ineffective.
The medicine, molnupiravir, was developed with Ridgeback Biotherapeutics and demonstrated to reduce hospitalisation and fatalities by roughly 30 percent in a clinical study of high-risk people early in the course of the illness.
The approval authorises the medicine to be used for mild-to-moderate COVID-19 infection and, in combination with the Pfizer tablet, might be a critical tool in the fight against the rapidly spreading Omicron form, which has become prevalent in the United States.
According to trial results, Pfizer’s medicine was approved on Wednesday for persons aged 12 and older. It has been demonstrated to be approximately 90% effective in reducing hospitalisation and death in patients at high risk of severe illness.
According to the FDA, certain patients should avoid Pfizer’s two-drug combination because it contains an older antiviral called ritonavir, which has been shown to interact with certain other prescription medications. Additionally, it is not indicated for individuals who have significant renal problems.
Merck intends to distribute hundreds of thousands of treatment courses over the next several days and one million in the next weeks. Pfizer anticipates shipping around 250,000 courses during the next month.
According to Patrizia Cavazzoni, head of the FDA’s Center for Drug Evaluation and Research, clinicians first assess the availability of other therapies before prescribing Merck’s therapy.
The FDA has approved monoclonal antibodies as intravenous therapies, mostly for hospital usage, however availability is restricted and effectiveness against the Omicron form is lower.
According to FDA official John Farley, the antibody medication developed by GlaxoSmithKline and Vir Biotech — which has been demonstrated to be effective against Omicron — is projected to be in limited supply this winter.
Merck asserted that its therapy was superior to the Pfizer tablet.
“It does not require any additional drug to enhance its efficacy, and it can be used in a variety of special patient populations, including those with significant liver or kidney dysfunction,” Nick Kartsonis, Merck’s senior vice president of clinical research for vaccines and infectious diseases, told Reuters.
The FDA has prohibited Merck’s medicine from being used in patients less than 18 years old due to concerns that molnupiravir may impair bone and cartilage formation. The agency warned that the pill is not advised for usage during pregnancy. The agency urged males of reproductive potential to use a reliable form of birth control during and for at least three months following the final dosage of molnupiravir.
The medication is intended to be taken twice daily — four tablets each time — for five days, totaling 40 pills for the whole treatment period. In an agreement with the US government, the therapy was priced at around $700 per course for up to 5 million courses.
The US government has bought ten million courses of the Pfizer medicine at a cost of $530 each course, compared to Merck’s agreement to purchase up to five million courses of molnupiravir at a cost of $700 per course.
Merck’s head of worldwide public policy, Paul Schaper, stated that the corporation will send hundreds of thousands of treatment courses within a few days and a million treatment courses within a few weeks in the United States.
Merck has said that molnupiravir, which aids in viral replication, should be effective against any version, including the newly discovered Omicron type.