US clears Pfizer’s COVID-19 oral treatment, first for home use

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Dec. 22 (Reuters) – The United States on Wednesday cleared Pfizer Inc’s (PFE.N) COVID-19 antiviral pill for people 12 years and older at risk of serious illness, the first oral and home treatment as well as ‘a new tool against the fast-spreading Omicron variant.

Pfizer’s antiviral regimen, Paxlovid, was nearly 90% effective in preventing hospitalizations and death in patients at high risk for serious illness, according to data from the company’s clinical trial. Recent lab data suggests the drug retains its effectiveness against Omicron, Pfizer said. Read more

Pfizer has raised its production projections for 2022 to 120 million treatments from 80 million and has said it is ready to begin immediate delivery to the United States. The two-drug regimen consists of a new drug and a second, older antiviral called ritonavir.

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The U.S. government will have 265,000 courses of treatment by January and supply will increase over the following months, White House COVID-19 response coordinator Jeff Zients said in a briefing. The government expects to receive the 10 million courses it has ordered within six months. Read more

“The approval of Paxlovid is an important step that marks another step towards transforming COVID-19 into a much more manageable infection,” said Amesh Adalja, principal researcher at the Johns Hopkins Institute for Health Security.

“There are two key issues, however: it will be scarce in the coming weeks and its optimal use requires rapid diagnosis, which can be difficult with the ongoing testing issues that plague us,” Adalja added.

Pfizer said it has 180,000 treatment courses ready for shipment this year. The US government contract for 10 million courses of the drug is priced at $ 530 per course.

Food and Drug Administration decision to issue emergency authorization for treatment comes as United States battles spike in COVID-19 cases caused by Omicron variant, President Joe Biden announcing plans for more federal vaccination and testing sites.

The pills can fill a treatment gap opened by the Omicron variant, said William Schaffner, an infectious disease expert at Vanderbilt University School of Medicine. The most widely used monoclonal antibody treatments for COVID-19 have been shown to be less effective in fighting the variant and the supply of the only remaining treatment that works is limited, he said.

Paxlovid, a pill against Pfizer’s coronavirus disease (COVID-19), is seen manufactured in Ascoli, Italy, in this undated photo obtained by Reuters on November 16, 2021. Pfizer / Handout via REUTERS

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Monoclonal antibodies are typically administered intravenously in hospitals, are not widely available, and cost more than double the cost of the Pfizer pill.

The Omicron variant, first identified in southern Africa and Hong Kong in November, has spread across the world and now constitutes more than 70% of new coronavirus cases in the United States, according to the Centers for Disease Control and Prevention in the United States. Previous infection and vaccines have been shown in studies to only partially prevent infection with the variant, although a booster increases protection.

The FDA has said it has cleared Paxlovid for emergency use for the treatment of mild to moderate illnesses in adults and children 12 years of age and older who are at high risk of progressing to severe COVID-19.

The drug is available by prescription only and should be started as soon as possible after a diagnosis of COVID-19 and within five days of onset of symptoms, the FDA said. The pills should be taken every 12 hours for five days.

Although clinical trials did not include patients under the age of 18, Pfizer said, the approved adult dosage regimen is expected to result in comparable blood concentration levels of the drug in pediatric patients 12 years and older weighing in. less 40 kg (88.2 lbs).

The second drug, ritonavir, is known to interact with other prescription drugs. Pfizer said it should be manageable and suggested that most patients could reduce the dose of their other drugs while being treated for COVID-19.

Pfizer said it plans to file a new drug application with the FDA in 2022 in order to gain full regulatory approval.

Pfizer has agreed to allow generic manufacturers to supply versions of the treatment to 95 low- and middle-income countries through a licensing agreement with the international public health group Medicines Patent Pool (MPP).

A competing pill from Merck & Co (MRK.N) is under review by the FDA. The drug, molnupiravir, developed with Ridgeback Biotherapeutics, reduced the risk of hospitalization and death by 30% in one trial.

Pfizer stock closed more than 1% Wednesday at $ 59.45.

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Reporting by Dania Nadeem, Ankur Banerjee in Bengaluru, Carl O’Donnell and Caroline Humer in New York and Ahmed Aboulenein in Washington Editing by Nick Zieminski, Leslie Adler, Matthew Lewis and Cynthia Osterman

Our Standards: Thomson Reuters Trust Principles.


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