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The U.S. Food and Drug Administration on Thursday authorized Merck & Co’s anti-COVID-19 drug for a high-risk group of patients over the age of 18, a day after approving a similar treatment by Pfizer Inc. for patients. high risk over 12 years old.
Merck’s drug, molnupiravir, developed with Ridgeback Biotherapeutics, reduces hospitalizations and deaths by about 30%, according to a clinical trial among high-risk individuals in the early stages of the disease.
The agency authorized the drug to treat mild to moderate cases of COVID-19 in adults who are at risk for serious illness and who are unable to use alternative treatments for COVID-19.
The decision comes after a close vote in favor of authorization by an FDA panel of experts on November 30th.
Both Merck and Pfizer pills can be promising treatments for those with COVID-19, especially in the face of the rapid spread of Omicron, which is now the dominant variant in the United States.
“As new variants of the virus continue to emerge, it is essential to expand the range of COVID-19 therapies in the country using emergency authorization to use nt,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
The drug is not authorized for use in patients under 18 years of age because molnupiravir may adversely affect bone growth, the FDA said. The Pfizer pill was authorized Wednesday for people 12 and older.
Pfizer’s antiviral treatment, Paxlovid, was nearly 90% effective in preventing hospitalization and death in patients at high risk for serious illness, according to clinical trial findings./VOA
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