Merck Seeks Emergency Approval for COVID-19 Oral COVID Treatment

Merck Seeks Emergency Approval for COVID-19 Oral COVID Treatment

As I have noted many times before, an effective COVID-19 response plans will include focus in effective and inexpensive treatments.

It appears that a new treatment option may be on its way.

Merck plans to request emergency approval for an experimental oral COVID-19 antiviral drug, molnupiravir, after a late-stage trial indicated an approximate 50% risk reduction for hospitalization or death among patients with mild to moderate COVID-19.

An interim analysis, stemming from the Phase 3 MOVe-OUT trial, indicated 7.3% of patients who received molnupiravir were hospitalized or had died about a month later, compared with 14.1% of patients receiving a placebo. The company also reported no deaths in the treatment group, versus eight deaths in the placebo group.

“Merck plans to submit an application for Emergency Use Authorization (EUA) to the U.S. FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide,” the company said Friday.

The new medication was also proven to be consistently effective against all strains of COVID-19, including the Delta variant.

A pill to effectively treat COVID-19 has long been a major goal, and the new results quickly won praise from experts.

“This is a phenomenal result, I mean this is a profound game-changer to have an oral pill that had this kind of effect,” former Food and Drug Administration (FDA) Commissioner Scott Gottlieb said on CNBC.

Every participant in the study was unvaccinated and had at least one underlying health condition that increased their chances of developing a more serious case of COVID-19. Some of the most common health factors among participants included obesity, diabetes, heart disease and being over the age of 60.

The trial was conducted at more than 170 sites in countries including the United States, the United Kingdom, Japan, Taiwan and South Africa.

Merck’s new medication, molnupiravir, works by inhibiting the mechanisms by which the virus replicates.

The company name for molnupiravir is ‘EIDD 2801’ the ‘E’ indicating it was developed at Emory University. Antiviral drugs, and this includes the much-in-demand Remdesivir, work by inhibiting the process by which the virus replicates. In the case of molnupiravir, when tested on cultured cells, it works by altering critical enzymes that are necessary for the virus to begin replicating in the body’s host cells.

A key challenge has been that many such antivirals, following a similar mechanism, are not effective as oral pills. However, the Merck pill reportedly appears to have overcome this barrier and adds to its promise as a ‘game-changing’ pill amid the COVID-19 crisis.

Dean Li, Merck’s head of research and development, told medical news website Statnews that the name molnupiravir was also a tangential reference to the weapon of Thor, who is one of the Avengers and a fictional hero of the Marvel Comics Universe. Thor’s hammer is called Mjolnir. “This is a hammer against SARS-CoV-2 regardless of the variant,” said Li. The suffix ‘-avir’ is a common one used for anti-viral drugs.

The pills offer an alternative to the injection cycles associated with monoclonal antibody treatments, which have been the most effective option so far in treating early-stage COVID-10 infections. They are also less expensive and apparently have minimal side effects.

The federal government is paying about $700 per course of treatment. That is about one-third of the cost of a monoclonal antibody treatment. The plan is to make the pills free for Americans, like the Covid vaccines. Whether there are any out-of-pocket costs is likely to be determined after the pills are authorized for use by regulators.

Merck did not report any serious side effects among volunteers in its clinical trial. Any side effects, which typically involve mild complaints like headaches, can be hard to distinguish from feeling ill from Covid, researchers said.
Are there other antiviral pills on the way?

Pfizer is developing a similar pill, as are Atea Pharmaceuticals and Roche. Results from their clinical trials are expected within the next few months. They are unlikely to be available for use until next year.

However, it must be noted that emergency use authorization application does not necessarily mean approval. A study published in the Journal of Infection Diseases reports that NHC (an initial metabolite of molnupiravir) it mutagenic in mammalian cells.

NHC also displays host mutational activity in an animal cell culture assay, consistent with RNA and DNA precursors sharing a common intermediate of a ribonucleoside diphosphate. These results indicate highly active mutagenic ribonucleosides may hold risk for the host.

With this in mind, let’s hope the Food and Drug Administration does a proper risk evaluation without undo influence of Big Pharma. After all, we were promised the cure would not be worse than the disease.

One last note: I have seen social media statements indicating molnupiravir is repackaged ivermectin. It is not.

Chemist's PSA in the face of a likely coming misinformation storm: No, Merck's molnupiravir is NOT repackaged ivermectin — they are vastly different in structure and intended action. pic.twitter.com/iIXBSZrwbw

— Chris Cramer (@CRO_Cramer) October 1, 2021

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