The FDA approves Pfizer’s Covid treatment, the first oral antiviral drug cleared during a pandemic


Food and Drug Administration granted emergency permit on Wednesday PfizerCovid remedies are a major milestone in promising to revolutionize the fight against the virus.

Recommended for people at high risk of developing severe Covid-19, the drug may be available to patients as early as this weekend. Pfizer CEO Albert Bourla told CNBC earlier this month that he had already shipped several tablets to the United States for prescription as soon as FDA approval was obtained. The Centers for Disease Control and Prevention is expected to approve the distribution, mark it for approval, and follow up quickly.

The FDA has cleared pills for patients aged 12 years and older with mild to moderate Covid who are most likely to be hospitalized or not alive. Authorities said it should be prescribed as soon as possible after diagnosis and within 5 days of the onset of symptoms.

“Today’s approval introduces the first treatment for COVID-19 in the form of tablets that are taken orally. This is a major step forward in the fight against this pandemic,” the FDA’s drug said. Dr. Patrizia Cavazzoni, director of the evaluation center, said. The study said in a statement. “This approval provides a new tool for combating COVID-19 during critical periods of the pandemic, making it easier for patients at high risk of developing new variants to develop severe COVID-19 to receive antiviral treatment. I promise to do it. “

The company reiterated on Wednesday that it was ready to start delivery in the United States soon.

Pfizer tablets are the first FDA-approved oral antiviral drug specifically designed to combat Covid. Approval is a major turning point in the pandemic, as hospital systems across the United States have been hit by a wave of delta infections and are now preparing for another wave of patients infected with the highly contagious Omicron variant.

This medicine provides a new tool for the arsenal to fight Covid. Vaccines have proven effective in preventing serious viral illnesses, but healthcare providers have given drugs to treat tens of millions of unvaccinated people in the United States. I need it. If the pill is delivered in time, it may help reduce the burden on the medical system during the expected wave of Omicron infections.

The United States has purchased 10 million courses of Pfizer’s treatment, Paxlovid, in a $ 5 billion transaction. President Joe Biden said in November that his administration is working to make treatment available for free. Biden said last month that delivery would begin by the New Year and continue until 2022.

Merck has signed a contract with the US government to supply at least 3 million courses of pills, Molnupiravir, for $ 2.2 billion.

Pfizer’s treatment is given twice daily in two 150 mg tablets along with a 100 mg tablet of the HIV drug ritonavir. HIV drugs help slow down a patient’s metabolism. This allows Paxrovid to remain active in the body for extended periods of time at higher concentrations.

Merck’s 800 milligram pills are taken every 12 hours for 5 days after the onset of symptoms. This drug was developed by Ridgeback Biotherapy.

According to final clinical trial data submitted by Pfizer to the FDA earlier this month, Pfizer tablets were 89% effective in preventing hospitalization. Early data showed that Merck pills were 50% effective in preventing hospitalization, but more extensive trials showed that pills were 30% more effective in preventing hospitalization. understand.

Bourla said he hopes Paxrovid will continue to be very effective in treating people infected with the Omicron variant. Pills target enzymes that the virus needs to replicate. Bourla said it is very difficult for the virus to mutate in a way that does not require an enzyme called a protease.

“It’s very difficult for the virus to make a strain that can survive without this protease,” Bourla told The Wall Street Journal during an interview at a conference earlier this month. “It’s not impossible. It’s very difficult.”

Vaccines, on the other hand, target the spike proteins that the virus uses to invade human cells. Spike made a significant mutation during the pandemic process. This made it more difficult for the antibodies produced by the shot to block the virus from adhering to the cells. For example, the Omicron variant has about 30 mutations in spikes.

Merck’s experimental Covid-19 treatment called molnupiravir

MERCK & CO INC | Via Reuters

According to actual South African data, double dose vaccines like Pfizer are still effective in preventing serious illness. And Pfizer’s booster shots greatly enhance that protection. However, according to the data, the first two dose series are currently only about 33% effective in preventing infection. Tablets help treat people when infected.

Merck’s drug was approved by the FDA’s panel of experts, the Antimicrobial Advisory Board, with a narrow vote of 13-10. The panel supported the pill, but the meeting was controversial. Some doctors have expressed concern about the potential side effects of the drug and its potential impact on the future evolution of the virus.

Molnupirvar mutates the virus and produces errors that impede its ability to replicate. Dr. James Hildress, CEO of Meharry Medical College in Nashville, Tennessee.

“Even with a very low probability of 1 in 10,000 or 1 in 100,000, this drug can induce escape mutants not covered by vaccines we do not cover, It can actually be devastating to the whole world, “Hildress told the panel in November.

Panel members also addressed whether pregnant women should take pills in limited circumstances if they have severe Covid. Molnupiravir induced birth defects in animal studies. Merck never intended pregnant women to use pills and did not include them in clinical trials.

The FDA approves Pfizer’s Covid treatment, the first oral antiviral drug cleared during a pandemic

Source link The FDA approves Pfizer’s Covid treatment, the first oral antiviral drug cleared during a pandemic

The post The FDA approves Pfizer’s Covid treatment, the first oral antiviral drug cleared during a pandemic appeared first on Eminetra.


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