Merck (NYSE: MRK) has announced that it is seeking the Food and Drug Administration's (FDA) approval for what could be the first pill sold to treat COVID-19. The oral antiviral drug, which in studies was shown to cut hospitalization and deaths by 50%, could provide a groundbreaking alternative to the current IV and injection COVID-19 treatments with FDA approval.
Merck's molnupiravir, developed in partnership with Ridgeback Biotherapeutics, is both cheaper to produce and easier to use than other medications currently being used to treat the coronavirus. The pharmaceutical company is seeking approval of emergency use of the drug for adult patients who are at risk of hospitalization for mild-to-moderate cases.
"The value here is that it's a pill so you don't have to deal with the infusion centers and all the factors around that," a vice president of Merck's unit on infectious diseases, Dr. Nicholas Kartsonis, said. "I think it's a very powerful tool to add to the toolbox."
The FDA's approval could come within a few weeks. The approval process will include an analysis of the side effects of the drug. During studies, patients given the medication showed the same side-effects as patients given a placebo, but details of those effects have not been released by Merck.
If the drug does receive approval, it could support the country's two-pronged approach to the coronavirus pandemic: prevention, in the form of vaccines, and treatment, through medications. Still, according to health officials and experts, the best way to address the pandemic is still the vaccine.
"It's much, much better to prevent yourself from getting infected than to have to treat an infection," Dr. Anthony Fauci said regarding Merck's potential new drug.
Currently, nearly 70 million Americans remain unvaccinated, but recent weeks have seen an increase in individuals getting the shot, largely due to workplace requirements and boosters. Both COVID-19 deaths and new reported cases have been down in the last few weeks. However, health experts are concerned that these gains could be lost once the winter weather hits.
While the vaccine may be the key to cutting cases, the U.S. government has committed to purchasing more than $1 billion worth of Merck's new drug if it gets approval, based on preliminary figures. The government has placed an order for treatment for 1.7 million people, with each round costing $700. That $700 figure is subject to change as the drug moves through the approval process.
"We set that price before we had any data, so that's just one contract," said Kartsonis. "Obviously we're going to be responsible about this and make this drug as accessible to as many people around the world as we can."
While $700 may seem steep, it's still cheaper than current antibody drugs that require difficult and costly production process. In order to help lower-income countries gain access to the new oral antiviral, Merck has authorized several Indian generic drug producers to sell low-cost versions of the drug. Prices will be determined on sliding scale based on the purchasing country's economic means.
It might be the first to reach the finish line, but Merck isn't the only company looking to produce an oral treatment for COVID-19. Both Pfizer (NYSE: PFE) & Roche (OTC: RHHBY) are looking into similar drugs and could show results in the next weeks or months.
AstraZeneca (NASDAQ: AZN), meanwhile, is seeking approval for a long-acting antibody drug which is meant to be used to protect immunocompromised people who don't respond to the vaccine with an alternative preventive option.