The FDA advisory committee of the US Food and Drug Administration (FDA) has recommended that Merck and MSD of the US give emergency use approval for ‘molnupiravir’, a COVID-19 treatment.
As a result, it is expected that emergency use of ‘molnupiravir’ will be approved in the United States as well as in the United Kingdom within this year.
This is the report by Lee Dong-heon.
The US FDA advisory committee recommended the emergency use of ‘molnupiravir’, an oral COVID-19 treatment developed by US pharmaceutical companies Merck and MSD on the 30th local time.
After a long discussion over the efficacy and dangers of the drug, the recommendation was passed by a narrow margin.
[조이스 유 / 미 연방 공무원 : 투표 결과 찬성 13표, 반대 10표, 기권 0표입니다.]
The pill form molnupiravir reduces the risk of severe worsening or death if taken within 5 days of the onset of symptoms of COVID-19.
However, the results of the meeting drew attention as the efficacy initially known as 50% was only 30% in the final clinical trial.
The FDA Advisory Committee has concluded that the benefits of using this drug outweigh the potential risks.
In particular, we believe that it is necessary for adult patients who have underlying diseases such as obesity and asthma, or who are at risk of exacerbation due to old age.
However, it should not be used by pregnant women and requested the FDA to recommend additional precautions, including pregnancy testing, before using this drug.
MSD said it will allow patients to self-medicate at home as prescribed by their doctors, which will ease the burden on hospitals and help curb deaths.
It was also expected to be effective against omicron mutations.
[니콜라스 카르트소니스 박사 / MSD 연구원 : 다른 변이의 경우 이미 약효가 입증됐는데, 오미크론에서도 이들 변이에서 볼 수 있는 같은 변화가 감지됩니다.]
Following this recommendation, it is expected that emergency use approval for COVID-19 treatment will be granted in the United States as well as in the United Kingdom within this year.
This is YTN Lee Dong-heon.
YTN Lee Dong-heon ([email protected])
[저작권자(c) YTN & YTN plus 무단전재 및 재배포 금지]