Merck & Co. and his partner Ridgeback Biotherapeutics LP applied for emergency use authorization in the United States of molnupiravir, which brings the pill closer to becoming the first oral antiviral treatment to combat Covid-19.
The companies said in a statement Monday that they submitted a request to the U.S. Food and Drug Administration (FDA) to the use of molnupiravir in the treatment of mild to moderate covid-19 in adults at risk of developing a serious illness that may require hospitalization.
The companies are expected to apply for clearance from regulatory authorities around the world in the coming months after an interim analysis of clinical trial data found it cut the risk of hospitalization for such patients in half.
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“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for approval of molnupiravir to the FDA within 10 days of receiving the data.” , said Robert M. Davis, CEO and President of Merck.
“We look forward to working with the FDA in reviewing our application and with other regulatory agencies as we do everything we can to get molnupiravir to patients around the world as quickly as possible.”
Molnupiravir can be given to patients at home, unlike the antiviral remdesivir from Gilead Sciences Inc. and other monoclonal antibody therapies, which are given by intravenous infusion usually in a hospital or clinic. Treating COVID-19 patients at home avoids the risk of transmitting the virus to medical personnel and other patients.
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A five-day course of molnupiravir would cost about $ 700 per patient: a third of what a monoclonal antibody treatment costs, according to the New York Times. Safe, well-tolerated, affordable, and easy-to-administer antivirals are ideal treatments because they directly counteract the virus, limiting its damage to the body and the duration of illness. Steroids and anticoagulants that have been shown to improve survival in hospitalized patients do not directly fight the virus, but rather prevent a worsening of covid symptoms.
Merck reiterated that it expects to manufacture 10 million treatments by the end of 2021 and that it has more doses scheduled for production in 2022.. The drug maker agreed in June to a US $ 1.2 billion supply contract with the US government, under which it will provide 1.7 million treatments once the drug is authorized for emergency use or approved by the FDA.
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