Here is why Merck wants FDA Approval for molnupiravir

By:
on Oct 11, 2021
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  • Merck seeing emergency use authorization of its antiviral tablet in treating COVID-19 patients.
  • Data from the third phase trial showed molnupiravir reduces chances of hospitalization by 50%.
  • Merck expects the drug to hit the market by the end year

Merck & Co. Inc. (NYSE: MRK) announced that it had sought the Food and Drug Administration’s permission to use its investigational antiviral tablet in the treatment of mild to moderate Covid-19 adult patients on an emergency basis.

The request came after phase three clinical study results, which the company released on October 1, 2021. The data revealed that the drug, known as molnupiravir, lowered the likelihood of patients newly diagnosed with COVID-19 being hospitalized by around 50%.

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Merck’s molnupiravir prevents coronavirus from replicating

The medicine works by preventing the virus from replicating inside the body. Merck’s molnupiravir, unlike Gilead Sciences’ injectable medication remdesivir, can be used orally. It would be the first tablet to treat COVID-19 if approved by the FDA, a possible game-changer in the fight against the coronavirus, which kills an average of 1,600 Americans daily.

Merck CEO Robert Davis said:

“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data.”

By the end of the year, the pill could be available in the United States. Merck co-developed the medicine with Ridgeback Biotherapeutics. It is currently working with regulatory bodies around the world to file emergency use or authorization applications “in the coming months.”

The company promised earlier this year to supply the US with 1.7 million molnupiravir doses if it wins EUA or full FDA approval. According to The New York Times, a five-day medicine prescription will cost the federal government roughly $700 per patient, which is about a third of what monoclonal antibodies currently cost.

Companies developing antiviral drugs against COVID-19

Although vaccinations are still the best protection against the coronavirus, US health experts and officials are optimistic that drugs such as Merck’s tablet will keep COVID-19 from progressing in those getting infected and avoid hospital trips.

According to World Health Organisation’s executive director for Health Emergencies Program, medications such as Merck’s pill are some sort of “holy grail” for treatment.

Besides Merck, other Pharmaceutical companies are also working in creating antiviral pills. For instance, Pfizer, which created one of the approved COVID-19 vaccines in the US, is working on an antiviral treatment that will be available by the end of 2021, according to its CEO Albert Bourla.