FDA approves COVID-19 antiviral pills for first at-home treatment

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(Video Credit: Fox News)

The Food and Drug Administration (FDA) has received emergency authorization to approve two antiviral pills, one from Pfizer and one from Merck, for the oral treatment of COVID-19 at home to be used immediately after symptoms occur.

Pfizer’s Paxlovin pill was approved on Wednesday and Merck’s Molnupiravir pill received a thumbs up on Thursday.

As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorization, while continuing to generate additional data on their safety and effectiveness,” Dr. Patrizia Cavazzoni, who is the director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

Pfizer’s pill is recommended for people at a high risk of developing severe COVID and could be available to patients as early as this weekend. Pfizer CEO Albert Bourla told CNBC previously that the company has already shipped some of the pills to the U.S. so they can be prescribed as soon as the FDA authorization comes through. The Centers for Disease Control and Prevention is expected to quickly authorize its distribution.

The pill is cleared for patients 12 and up with mild to moderate COVID who are most likely to end up hospitalized or to die from the virus. The FDA said it should be prescribed immediately after diagnosis and within five days of symptoms occurring.

“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” Cavazzoni noted. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”

Pfizer’s pill is administered in two 150 milligram tablets along with a 100-milligram tablet of an HIV drug called ritonavir, twice daily. The HIV drug helps slow the patient’s metabolism, which allows Paxlovid to remain active in the body at a higher concentration for a longer period of time.

The pill was found to be 89 percent effective in preventing hospitalization, according to final clinical trial data submitted by the company to the FDA earlier in December. It targets an enzyme the virus needs to replicate.

The FDA warned that the pills are not substitutes for vaccinations and that Molnupiravir is not a preventative drug.

(Video Credit: CNBC Television)

Cavazzoni commented that Merck’s pill will be “limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death.”

Fox Business is reporting that the use of Molnupiravir in patients under the age of 18 is not authorized because it could affect bone and cartilage growth. Molnupiravir has been found to induce birth defects in animal studies. It also has potentially severe side effects according to doctors.

Merck’s 800-milligram pill is taken every 12 hours for five days after symptoms occur.

Initial data showed Merck’s pill was 50 percent effective at preventing hospitalization, but a broader trial found that the pill was 30 percent effective at preventing hospitalizations.

The drug prompts the virus to mutate and produce errors that inhibit its ability to replicate, according to Merck. Many find that extremely alarming.

“Even if the probability is very low, 1 in 10,000 or 100,000, that this drug would induce an escape mutant from which the vaccines we have do not cover, that could be catastrophic for the whole world actually,” Dr. James Hildreth, who is the CEO of Meharry Medical College in Nashville, Tennessee, told the FDA panel in November.


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