The agency is starting this review to support national authorities who may decide on its early use for COVID-19, for example in emergency use settings, prior to marketing authorization, according to the statement.
The agency’s human medicines committee (CHMP) will look at data from a study comparing the effect of Paxlovid with that of a dummy treatment (placebo) in non-hospitalized patients with mild to moderate COVID-19 who were at high risk of progressing to severe disease.
“The preliminary results indicate that Paxlovid reduced the risk of hospitalization or death compared with placebo when treatment was given within 3 or 5 days of the start of symptoms. The CHMP will also review data on the medicine’s quality and safety,” the statement noted.
Paxlovid is an oral antiviral medicine that reduces the ability of SARS-CoV-2 (the virus that causes COVID-19) to multiply in the body. The active substance PF-07321332 blocks the activity of an enzyme needed by the virus to multiply.
Paxlovid also contains a low dose of ritonavir (a protease inhibitor), which slows the breakdown of PF-07321332, enabling it to remain longer in the body at levels that affect the virus. The medicine is expected to reduce the need for hospitalization in patients with COVID-19. (ILKHA)
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