Health

Pfizer Asks US Officials To Approve Promising COVID-19 Pill

On Tuesday, Pfizer asked US regulators to authorize its experimental COVID-19 pill, setting the stage for the likely launch of a promising home-use drug this winter.

The company said new infections are on the rise again in the United States, mainly due to hotspots in states where colder weather is forcing more Americans to stay indoors.

Pfizer tablets have been shown to significantly reduce hospitalizations and deaths among people with coronavirus infection. The FDA is already reviewing a competing pill from Merck, and several smaller drug manufacturers are expected to seek approval for their own antiviral pills in the coming months as well.

“We are moving forward as quickly as possible in our efforts to place this potential treatment in the hands of patients, and we look forward to working with the US FDA to review our application,” Pfizer CEO Albert Burla said in a statement.

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Specifically, Pfizer wants the drug to be available to adults who have mild to moderate COVID-19 infection and who are at risk of serious illness. This is similar to how other drugs are currently used to treat the disease. But all FDA-approved treatments for COVID-19 require intravenous or injection given by a healthcare professional in a hospital or clinic.

The FDA will hold a public meeting on Merck tablets later this month to seek outside expert input before making a decision. The agency is under no obligation to hold such meetings, and it is not yet known whether Pfizer will undergo a similar public review.

Some experts predict that COVID-19 treatments will eventually be combined to better protect against the virus’s worst effects.

Earlier this month, Pfizer said its pills reduced hospital admissions and deaths by 89% among high-risk adults who had early symptoms of COVID-19. The company studied its pills in people who had not been vaccinated and faced the worst risk of contracting the virus due to age or health problems such as obesity. If permitted, the FDA will have to weigh the availability of the pill for vaccinated people with breakthrough infections, since they did not participate in the initial tests.

For best results, patients should start taking the pills within three days of symptom onset, highlighting the need for prompt testing and diagnosis. This could be a problem if another surge in COVID-19 leads to the delays and shortages of tests seen last winter.

Pfizer is part of the family of antiviral drugs known as protease inhibitors that are decades old. They revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme that viruses need to reproduce in the human body. This is in contrast to the Merck pill, which causes tiny mutations in the coronavirus to the point where it cannot reproduce.

On Tuesday, Pfizer signed an agreement with a UN-backed group to allow generic manufacturers to produce low-cost versions of the tablets for specific countries. Merck has a similar deal for its pills that was authorized in the UK earlier this month.

The US has approved another COVID-19 antiviral drug, remdesivir, and has authorized three antibody therapies that help the immune system fight the virus. But they usually have to be administered medically as long-term infusions, and limited supplies have been limited by the latest surge in the delta variant.

The US government has already committed itself to purchasing Merck tablets. Federal authorities were in talks with Pfizer to purchase millions of doses of its pills, according to an official familiar with the matter.


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