Pfizer oral COVID-19 pill gets U.S. authorization for at-home use

Dec 22 (Reuters) – The U.S. on Wednesday authorized Pfizer Inc’s (PFE.N) oral antiviral COVID-19 pill for at-risk peopleaged 12 and above, making it the first at-home treatment for the coronavirus and a potentially important tool in the fight against the fast spreading Omicron variant.

Data from Pfizer’s clinical trial showed its antiviral regimen, Paxlovid, was 90% effective in preventing hospitalizations and deaths in patients at high risk of severe illness. Recent lab data suggests the drug retains its effectiveness against Omicron, Pfizer said.

“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,” Patrizia Cavazzoni, director of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, said.

Pfizer said it was ready to start immediate delivery in the U.S. of the treatment – whose two drug regimen includes a new medicine and a second older antiviral called ritonavir – and raised its 2022 production projections to 120 million courses of treatment from 80 million.

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Categories: Health

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  1. Pfizer Inc said on Wednesday the US Food and Drug Administration (FDA) authorized its antiviral Covid-19 pill, making it the first at-home treatment for the coronavirus that is expected to become an important tool in the fight against the fast spreading Omicron variant.

    Data from Pfizer’s clinical trial showed its two-drug antiviral regimen was 90% effective in preventing hospitalizations and deaths in patients at high risk of severe illness. Recent lab data suggests the drug retains its effectiveness against Omicron.

    The agency authorized the oral drug for the treatment of high-risk adult patients and pediatric patients at least 12 years of age with Covid-19 outside of the hospital.

    The company said it was ready to start immediate delivery in the US and raised its production projections to 120m courses of treatment from 80m in 2022.

    The US government’s contract for 10 million courses of the Pfizer drug is priced at $530 per course.

    Pfizer’s pills, taken with the older antiviral drug ritonavir, will be sold under the brand name Paxlovid.

    The pills are meant to be taken every 12 hours for five days beginning shortly after the onset of symptoms.

    https://www.theguardian.com/world/2021/dec/22/fda-authorizes-antiviral-pill-treat-covid-at-home

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