Merck Submits COVID Treatment Pill for FDA Approval After Study Yields Promising Data
Drug-maker Merck says it has developed a pill that can treat mild to moderate cases of COVID-19, and the company is asking federal regulators to allow it to be used.
On Monday, the company announced that it has submitted a request for an Emergency Use Authorization from the Food and Drug Administration for a drug it has called molnupiravir, according to a statement on the company’s website. The drug is an “oral antiviral medicine that can be taken at home shortly after diagnosis with COVID-19,” the company said.
The statement said the drug, developed through a partnership with Ridgeback Biotherapeutics, is designed to treat “mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.”
The company said that according to its research, which has not been independently studied, “molnupiravir reduced the risk of hospitalization or death by approximately 50%.”
Even before the FDA has approved the drug, it has been a hot seller. The federal government has ordered enough pills to treat 1.7 million people at a price of about $700 per person, according to The New York Times.
FDA approval is expected within weeks after it reviews the data submitted by the company.
The process for allocating the pills will likely mirror that of coronavirus vaccines, with states being given the pills to distribute in whatever fashion they want, senior administration officials said, according to the Times.
The pill is the first to treat COVID. Merck expects to sell enough pills to treat 10 million people this year, and do an even bigger business next year. Australia, Malaysia, Singapore and South Korea have already struck deals with Merck for the drug.
Other pills are on the way. Pfizer and Atea Pharmaceuticals-Roche have medicines that are now undergoing trials.
The Merck pill, which could become the first oral antiviral COVID treatment, forces the SARS-CoV-2 coronavirus to mutate itself to death https://t.co/RsXGbWgBkh
— nature (@Nature) October 11, 2021
The Merck pill is not one dose, but rather a five-day course of four pills per day. The drug inserts errors into the genetic code of the virus, which means it is likely not to be recommended for anyone who is pregnant or seeking to become pregnant.
Merck is currently seeking emergency use authorization for high-risk adults, which in its trial was usually people over 60 or those with obesity, diabetes or heart disease who were in younger age groups.
The trials did not include those who had been vaccinated, which leaves, for now, unclear whether the drug can be given to people who have been vaccinated.
Some questioned the cost of the drug.
Pharma giant Merck is facing accusations of price gouging after it charged the U.S. more than $700 per patient for a taxpayer-funded coronavirus treatment that, according to research, costs just $17.74 to produce.https://t.co/BSYYnPmRBl
— Robert F. Kennedy Jr (@RobertKennedyJr) October 8, 2021
Pharma company Merck used government funds to develop a new Covid medicine.
The drug costs them less than $18 to produce. They’re charging the U.S. government $712 — 40 times the price to produce it.
Their sales could reach $7 billion by the end of the year.
An outrage.
— Robert Reich (@RBReich) October 7, 2021
The company’s statement portrayed side effects as minimal, but did not discuss them at length.
“The incidence of any adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). The incidence of drug-related adverse events was also comparable (12% and 11%, respectively), and fewer subjects in the molnupiravir group discontinued therapy due to an adverse event compared to the placebo group (1.3% and 3.4%, respectively),” the company’s statement said.
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