Merck Pushes for FDA Approval of Its Antiviral COVID-19 Pill.

    On Monday, American multinational pharmaceutical company, Merck, requested the U.S. Food and Drug Administration (FDA) to grant an emergency use authorization (EUA) for Molnupiravir, its COVID-19 antiviral pill.

    CEO and president of Merck, Robert M. Davis, shared in a statement that Molnupiravir was developed alongside Ridgeback Biotherapeutics.  He explained that the experimental antiviral pill is seen as a more convenient means of treating “mild-to-moderate COVID-19 in adults,” particularly those who are highly likely to suffer from the more severe effects of the virus.

    Davis explained that Molnupiravir is designed to prevent the COVID-19 virus from activating the enzyme that allows it to replicate. Clinical tests also show that it effectively controls even the more virulent Delta strain of the virus and is seen to prevent hospitalization by as much as 50 percent.

    The CEO and president of Merck also stressed that the “extraordinary impact of this pandemic demands that we move with unprecedented urgency.”

    Wendy Holman, CEO of Ridgeback Biotherapeutics, related that acquiring the FDA’s go signal regarding the EUA for Molnupiravir is a “critical step.” She shared that the antiviral pill is aimed at making treatment available to people “who may benefit from an oral antiviral medicine that can be taken at home shortly after diagnosis with COVID-19.”

    She also expressed her gratitude to the clinical investigators and patients who helped them gather the necessary data to steer Molnupiravir in the right direction in the fight against COVID-19. “Without their significant contributions, today’s achievement would not be possible,” she emphasized.

    Notably, Monday’s announcement revealed that the U.S. government has already established a supply agreement with Merck if the requested EUA is granted. As a result, approximately 1.7 million doses of Molnupiravir will be allotted to the former as soon as the FDA green lights the authorization request.

    A former FDA Commissioner, Scott Gottlieb, shared that Molnupiravir may be a “game-changer” and predicted that if the EUA pushes through, the pandemic “would likely come to an end.”

    The FDA still hasn’t given its comment or update on the approval of Molnupiravir’s EUA as yet.

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