US FDA Delays Its Decision on Covid-19 Antibody Therapy of Roche/Regeneron


Just as the covid-19 antibody combination of Regeneron known as REGEN-COV has been sidelined in the United States because of the Omicron covid-19 variant, the drug is now facing another delay in getting the approval from the US FDA.

The company said that, the Food and Drug Administration (FDA) of the United States has now extended the review of the REGEN-COV by around three months to 13th July 2022. The US FDA is also wanting to take time for the purpose of reviewing the additional data on how well the therapy can possibly prevent the corona virus before the exposure of the therapy to the virus.

An approval from the US FDA in what has been known as the pre-exposure prophylaxis setting is going to be an expansion from the existing emergency use authorization of REGEN-COV, which currently only covers the treatment of the mild-to-moderate and non-hospitalized patients and the corona virus prevention after the exposure to the novel corona virus. Currently, the company is now seeking the complete approval for all the three uses of the therapy.

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The company ‘Regeneron’ has combined it corona virus prevention analysis for the REGEN-COV in both the pre and post exposure settings. In the setting of high-risk household with the confirmed corona virus cases, the REGEN-COV has decreased the risk of the symptomatic corona virus by 81.4 percent among the other individuals in the same household during the first month after the investigation was conducted.