01.12.2021, 10:57
US Regulator Recommends Merck Coronavirus Pill for Use
Source: OREANDA-NEWS
OREANDA-NEWS. A US Food and Drug Administration (FDA) advisory panel has recommended by a majority vote that Merck's anti-COVID-19 pills be approved, The Hill reports.
Thirteen board members were in favour of approving the drug, with ten opposed. The drug has been approved for adult patients who are at risk of severe disease, including those with co-morbidities.
The publication points out that the closed vote was held because of experts' concerns about the overall effectiveness of Merck's drug, as well as possible complications in pregnancy. "I see this as an incredibly difficult decision. But I can see scenarios where it [drug approval] has benefits and so it makes sense to me,"- said committee chair Lindsay Baden.
According to The Hill, those who voted against it pointed to the "modest" effectiveness of the pill as reflected in the latest data.
The FDA published its review of Merck's experimental antiviral pill on 26 November. The regulator said at the time that the drug was effective against COVID-19, but could pose a risk to foetal development in pregnant women. In addition, about 2% of patients experienced diarrhoea after taking the pill.
In addition to Merck, another US pharmaceutical company, Pfizer, is producing coronavirus tablets. At the beginning of November, Pfizer announced the completion of Phase II trials of COVID-19 in Paxlovid tablets. Pfizer stressed that the drug can reduce the risk of hospitalisation or death after infection with coronavirus by 89%.
Thirteen board members were in favour of approving the drug, with ten opposed. The drug has been approved for adult patients who are at risk of severe disease, including those with co-morbidities.
The publication points out that the closed vote was held because of experts' concerns about the overall effectiveness of Merck's drug, as well as possible complications in pregnancy. "I see this as an incredibly difficult decision. But I can see scenarios where it [drug approval] has benefits and so it makes sense to me,"- said committee chair Lindsay Baden.
According to The Hill, those who voted against it pointed to the "modest" effectiveness of the pill as reflected in the latest data.
The FDA published its review of Merck's experimental antiviral pill on 26 November. The regulator said at the time that the drug was effective against COVID-19, but could pose a risk to foetal development in pregnant women. In addition, about 2% of patients experienced diarrhoea after taking the pill.
In addition to Merck, another US pharmaceutical company, Pfizer, is producing coronavirus tablets. At the beginning of November, Pfizer announced the completion of Phase II trials of COVID-19 in Paxlovid tablets. Pfizer stressed that the drug can reduce the risk of hospitalisation or death after infection with coronavirus by 89%.
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