FDA advisory panel endorses Merck’s COVID-19 pill, but it was a close vote
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FDA advisory panel endorses Merck’s COVID-19 pill, but it was a close vote
The FDA Antimicrobial Narcotics Advisory Committee met today, as anticipated, to decide whether to recommend Molnupiravir, oral antivirus drug, as a new care option for Covid-19. The sound is now in, and even though there are many opposing, advisory panels finally recommend that Molnupiravir accept authorization of Emergency Use (EUA).
Recommendations, not authorization
Like the Covid-19 vaccine, the recommendation does not mean the treatment of Merck’s oral antivirus has been authorized to use. Conversely, the recommendation of the panel paved the way for the FDA to make his own decisions about whether it would request EUA company. The CDC also needs to decide whether it supports drugs, which are intended for adults who have Covid-19 light and moderate and are at high risk of severe results.
The panel finally voted 13 to 10 support the administration of molnupiravir emergency authorization, which will be the first oral antivirus drug designed to treat Covid-19. Medicines, which come from the Merck Biotorapy and Ridgeback, must be taken every 12 hours for five days after the symptoms of Covid-19 manifests.
Big question still exists
Some experts on the committee explain the reason narrow votes (through NBC), including concerns about the efficacy of drugs, potential birth defects, and ongoing questions about whether the drug can cause additional virus mutations that make covid-19 vaccines less effective.
Merck SVP from Clinical Research Nicholas Kartsonis told NBC that the pharmaceutical company did not have info about the chances of the medicine could cause mutations of worries. Note, Molnupiravir is designed to trigger mutations in the SARS-COV-2 virus that inhibits its ability to replicate. Senior Virologer FDA Patrick Harrington continued to explain that there was no enough info at this time to determine whether the drug could lead to a new transmission variant.
The FDA Advisory Committee has published documents about the meeting, summarizing drug efficacy, safety information, and trials that produce details. Adendum concludes with a record of “an urgent need that is not fulfilled for a safe and effective oral agent” designed to help treat Covid-19 in patients who have not been hospitalized.
“Risk-benefit assessment of Molnupiravir supports EUA,” Panel said in the document.
Excellency
The narrow recommendation of the panel came just a few days after Merck and Ridgeback published an update in the Molnupiravir trial, reported a decrease in protection compared to the results of a temporary analysis. Based on the latest results, the company said Oral antivirus treatment offers a relative risk reduction in severe Covid-19 30 percent, the decline from previously reported 48 percent.
Molnupiravir has the potential to join monoclonal antibodies as a treatment for Covid-19 patients at high risk, help prevent the development of more serious diseases that can cause hospitalization and death (through HHS). However, mixed response from experts, however, raises the question of whether the FDA will issue emergency authorization for molnupiravir and what limits can be placed on their use, assuming EUA is given.
