Washington (AP) —The Food and Drug Administration announced Thursday that it would request an outside expert to meet in late November to scrutinize Merck’s tablets for the treatment of COVID-19.
The November 30 meeting means that U.S. regulators will almost certainly not make drug decisions until December, and authorities will conduct a detailed review of the safety and efficacy of experimental treatments. is showing. Panelists may vote on whether Merck’s medication should be approved, but the FDA does not have to follow their advice.
This is the first time the FDA has convened an expert advisor before deciding on coronavirus treatment. Advisory board meetings have become a standard part of the process for reviewing vaccines.
Authorities have decided to convene a meeting to inform the decision, its supreme drug regulator said in a statement.
“In this case, we believe that public discussion of these data with the FDA’s advisory board will help ensure a clear understanding of the scientific data and information that the FDA is evaluating,” the FDA’s drug said. Dr. Patrizia Cavazzoni, director of the center, said.
The FDA said the meeting was scheduled as soon as possible at Merck’s request. The November date will allow institutional scientists to review the application before the meeting, the institution said.
Merck and its partner, Ridgeback Biotherapeutic, filed with the FDA on Monday requesting that adults with mild to moderate COVID-19 at risk of severe illness or hospitalization be allowed emergency use. This is about the same sign as an IV drug available.
Since last year, three IV antibody drugs have been approved to reduce COVID-19 hospitalization and mortality, but they are expensive, difficult to manufacture and must be provided by specialized equipment and medical professionals. If approved, Merck’s drug molnupiravir will be the first patient to take home to relieve symptoms and speed recovery.
Earlier this month, the company announced preliminary results that it halved hospitalizations and deaths for patients with early symptoms of COVID-19. Results have not yet been peer reviewed. This is the standard way to review such studies.
The company also did not provide details on the side effects of molnupiravir, but said the incidence of these problems was similar between those who took the drug and those who took dummy pills.
If approved, Merck’s drug could be the first pill to treat COVID-19, but it’s not the only one. Pfizer, Roche, and Appili Therapeutics are each researching similar drugs and will report results within the next few weeks to months.
FDA is unlikely to decide on Merck’s COVID pill before December | Chicago News
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