FDA approves Pfizer’s new coronavirus drug for high-risk adults


Jennifer Lorenzini | Reuters

The Food and Drug Administration on Thursday gave full approval to Pfizer’s new coronavirus treatment, Paxlovid, for adults at high risk of becoming seriously ill from the virus.

Paxlovid is specifically recommended for the treatment of mild to moderate COVID-19 in adults over the age of 50 and those suffering from certain medical conditions that put them at increased risk of hospitalization and death from COVID-19.

This includes people with diabetes, heart disease, cancer, or a weak immune system.

Three-quarters of adults in the United States are at risk of severe COVID-19.

Dr. Patrizia Cavazzoni said, “Today’s approval confirms that Paxlovid has met the agency’s stringent standards for safety and efficacy and has been shown to be effective against severe COVID-19, including in those who are immune. “It shows that it remains an important treatment option for people at high risk of progression.” The director of the FDA Center for Drug Evaluation and Research said in a press release.

In December 2021, the FDA first made paxlobid available under Emergency Use Authorization for high-risk individuals age 12 and older. Under that designation, the FDA rapidly approved this treatment based on preliminary clinical trial data.

The FDA’s latest decision means there is extensive clinical data showing that paxlovid is safe and effective.

The treatment consists of two drugs, nilmatrelvir, which blocks a key enzyme required for replication of the novel coronavirus, and ritonavir, which enhances the first drug’s ability to fight infections.

Both Pfizer and the FDA believe the treatment is an important complementary tool to vaccination, helping high-risk Americans cope with COVID-19 and ultimately save lives. there is

FDA researchers estimate paxlovid could “save 1,500 lives and avoid 13,000 hospitalizations each week” in the U.S. based on January COVID-19 infection rates bottom.

However, it is unclear how many will receive treatment later this year.

About 4 million doses of Paxlovid are available free of charge at pharmacies and health care providers nationwide, according to the Department of Health and Human Services. In addition, the US government has stockpiled 9.6 million doses.

As soon as that stock is depleted, the government plans to move distribution of Paxlobid to the commercial market.

This means Pfizer will sell Paxlovid directly to healthcare providers for a price the company did not disclose. Paxlovid currently costs about $530 per course.

Pfizer, whose sales of paxlovid surged to nearly $19 billion in 2022, expects revenue from the drug to decline 58% in 2023.

In March, the FDA’s independent advisory panel recommended the treatment based on three clinical trials from Pfizer.

One trial looked at high-risk adults who had not been vaccinated and had no previous COVID-19 infection.

An FDA review of the company’s data found that the trial showed an 86% risk of hospitalization or death among adults treated with paxlovid within 5 days of first symptom onset, compared with an 86% risk of hospitalization or death within 3 days of treatment. An 89% reduction was found in adults who received it.

The review said the trial did not identify any serious safety concerns, but the agency had issued warnings on 137 drugs that could cause serious side effects if they interacted with paxlovid.

The FDA said the most common drugs that pose safety problems are immunosuppressants, commonly used to treat HIV patients and organ transplant patients.

As of late January, the FDA’s Office of Surveillance and Epidemiology had documented 271 reports of serious adverse events potentially related to drug interactions with paxlobid, including 147 hospitalizations and 6 died.

FDA staff may be able to avoid these events by adjusting doses of certain drugs, increasing patient monitoring, and ensuring that product labels inform prescribers and patients of potential drug interactions. said there is.

Another concern for some doctors is Paxlovid’s “rebound cases.” That’s when a patient who has been treated recurs or tests positive soon after initial recovery.

These case reports occurred shortly after Paxlovid first entered the market.

Both President Joe Biden and former chief medical adviser Dr. Anthony Fauci appeared to have recovered from the novel coronavirus after taking antiviral cocktails, only to test positive again soon after.

An FDA review of Pfizer’s clinical trials found that overall rebound rates ranged from 10% to 16%, with “higher symptom rebound rates in patients receiving paxlovid” compared to those receiving placebo. , or moderate symptom rebound.”

According to the FDA’s review, these results persisted similarly regardless of the patient’s risk of severe disease and whether the omicron variant or the early strain of the virus predominated.

Correction: Approximately 4 million doses of Paxlovid are available in pharmacies and health care providers nationwide in the United States. An earlier version of this article incorrectly stated this number.



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