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Pfizer Requests Emergency Authorization for its Oral Antiviral Oral COVID-19 Treatment

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the staff of the Ridgewood blog

Ridgewood NJ, Pfizer requested emergency authorization for its antiviral oral COVID-19 treatment on Tuesday after a study found the pills dramatically reduced the risk of hospitalization.

The pharmaceutical giant is asking the Food and Drug Administration (FDA) to grant authorization for Paxlovid to treat mild to moderate COVID-19 in patients at a higher risk of hospitalization and death.

Pfizer’s request makes Paxlovid the second oral COVID-19 treatment that the FDA is considering for an emergency use authorization. Merck and its partner Ridgeback Biotherapeutics submitted for authorization of molnupiravir last month.

Pfizer previously said its trial found the pills reduced the risk of hospitalizations and deaths by 89 percent. The placebo group saw 27 hospitalizations and seven deaths, while three people who received Paxlvoid were hospitalized and none died.

The treatment, which involves three pills taken twice daily for five days, is recommended within three to five days of initial symptoms for those at higher risk of severe COVID-19 due to age or underlying medical conditions.

Pfizer announced today that it signed a voluntary license agreement with the Medicines Patent Pool, which is supported by the UN, to allow sub-licensed generic pharmaceutical manufacturers to produce its candidate oral antiviral COVID-19 treatment—a combination of ritonavir and a new antiviral, PF-07321332—pending regulatory authorization or approval.

Interim analysis from Phase 2/3 clinical trials found that the treatment demonstrated an 89% risk reduction in COVID-19-related hospitalization or death among high-risk adults when administered within 3 days of symptom onset. Under the terms of the agreement qualified manufacturers would be allowed to supply the treatment to 95 countries, including all low- and lower-middle income countries. Pfizer will not collect royalties on sales to low-income nations or other countries covered under the agreement while COVID-19 is classified as a Public Health Emergency of International Concern (PHEIC) by the WHO.

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