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A new analysis of clinical trial results shows that Merck’s antivirals to treat COVID-19 are significantly less effective than previously reported in October, the company announced Friday.
In an updated report, the drug company said its antiviral drug, called molnupiravir, showed a 30 percent reduction in hospitalizations and deaths. CCP (Chinese Communist Party) virus, Based on data from 1,433 patients.
In the company’s complete analysis, one patient died in the Mornupyravir group and nine died in the placebo group. The hospitalization and mortality rates for the Molnupiravir group in this study were 6.8%. The hospitalization and mortality rates for the placebo group were 9.7%.
In early October, a pharmaceutical company announced in an interim analysis of a Phase 3 study of treatment that it could cut the risk of hospitalization or death for adults who were considered at risk but not hospitalized in half. bottom.
7.3% of study participants who received the drug were hospitalized until day 29, compared to 14.1% of patients who received placebo, the company and its partner Ridgeback Biotherapeutics said at the time. Eight people died in the placebo group, but none in the molnupiravir-treated group.
The low efficacy of Merck’s drugs can have a significant impact on whether countries continue to buy pills.
In mid-October, Merck and its partners sought approval from the US Food and Drug Administration (FDA) for oral antivirals.
On Friday, the Associated Press reported that the FDA posted a review of Merck’s experimental COVID-19 pills ahead of next week’s public meeting where outside experts discuss the benefits and risks of the drug. U.S. health officials said the pills were effective, but questioned their safety during pregnancy.
The FDA asks experts if the benefits of the drug outweigh the risks of different patient groups, including pregnant women.
Similar to Pfizer’s experimental drug PAXLOVID, antiviral treatment should be given to patients as soon as possible to be most effective within a few days of the onset of symptoms.
Merck and Pfizer treatments are cheaper to manufacture and easier to administer than existing options such as Regeneron and Eli Lilly antibody therapies, which are primarily given as intravenous infusions.
In early November, US-based Pfizer announced that oral antiviral treatment would “significantly” reduce the risk of hospitalization and death for high-risk patients.According to one company Press release The pill, announced on November 5, was found in a scheduled interim analysis to reduce the risk of hospitalization or death from the CCP virus by 89% if patients receive the drug in time.
President Joe Biden said the United States had already secured millions of experimental antivirals by the time Pfizer released the analysis.
“If approved by the FDA, drugs to treat the virus in infected people may soon be available,” Biden said. “We have already secured millions of doses. Treatment will be another tool in the toolbox to protect people from the worst consequences of COVID.”
Currently, the only COVID-19 antiviral treatment that has been granted an emergency use authorization by the FDA is remdesivir, which is sold under the Veklury brand name.
According to the FDA, treatment should be combined with remdesivir and the anti-inflammatory oral drug baricitinib for patients over 2 years of age who require oxygenation, invasive ventilation, or extracorporeal membrane oxygenation (ECMO). It is included.
Reuters contributed to this report.
from NTD News
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