Namhlanje, i-US ULawulo lokuTya iziyobisi (FDA) ikhuphe isigunyaziso sosetyenziso olungxamisekileyo (EUA) lwe-Merck's molnupiravir kunyango lwesifo se-coronavirus esiphakathi ukuya kwimodareyitha (COVID-19) kubantu abadala abaneziphumo ezincumisayo zovavanyo lwentsholongwane oluthe ngqo lwe-SARS-CoV-2, kwaye abasengozini enkulu yokuqhubela phambili. ukuya kwi-COVID-19 emandundu, kubandakanywa ukulaliswa esibhedlele okanye ukufa, kwaye abo iindlela zonyango ezizezinye ze-COVID-19 ezigunyaziswe yi-FDA azifikelelekiyo okanye zifanelekile ngokwezonyango. I-Molnupiravir ifumaneka ngomyalelo kagqirha kuphela kwaye kufuneka iqalwe kwakamsinyane emva kokuba kufunyaniswe i-COVID-19 kwaye zingaphelanga iintsuku ezintlanu zokuqalisa kweempawu.
I-Molnupiravir ayigunyaziswanga ukuba isetyenziswe kwizigulana ezingaphantsi kweminyaka eyi-18 ubudala kuba i-molnupiravir inokuchaphazela ukukhula kwethambo kunye ne-cartilage. Ayigunyaziswanga ukuba sesichengeni kwangaphambili okanye uthintelo emva kokuba sesichengeni se-COVID-19 okanye ukuqaliswa konyango kwizigulana ezilaliswe esibhedlele ngenxa ye-COVID-19 kuba uncedo lonyango alukhange lubonwe ebantwini xa unyango luqaliswe emva kokulaliswa esibhedlele ngenxa ye-COVID- 19.
“Ugunyaziso lwanamhlanje lubonelela ngolunye unyango olongezelelweyo oluchasene nentsholongwane ye-COVID-19 ngendlela yepilisi enokuthi ithathwe ngomlomo. I-Molnupiravir kuphela kwiimeko apho ezinye FDA-unyango olugunyazisiweyo lwe-COVID-19 alufikeleleki okanye alufanelekanga ngokwezonyango kwaye luya kuba lukhetho oluluncedo kwabanye abaguli abane-COVID-19 abasemngciphekweni omkhulu wokulaliswa esibhedlele okanye wokusweleka, utshilo uPatrizia Cavazzoni, MD, umlawuli we-COVID-XNUMX. FDAIziko loVavanyo lweziyobisi kunye noPhando. Njengoko iintlobo ezintsha zentsholongwane ziqhubeka nokuvela, kubalulekile ukwandisa izixhobo zonyango ze-COVID-19 kusetyenziswa isigunyaziso sokusetyenziswa kukaxakeka, ngelixa uqhubeka nokuvelisa idatha eyongezelelweyo kukhuseleko nokusebenza kwabo.
I-Molnupiravir ayithatheli indawo yesitofu sokugonya kubantu ekucetyiswa ngabo ugonyo lwe-COVID-19 kunye nedosi yokomeleza. I FDA uphumeze isitofu sokugonya esinye kwaye ugunyazise abanye ukuba bathintele i-COVID-19 kunye neziphumo ezimandundu zonyango ezinxulumene nosulelo lwe-COVID-19, kubandakanya ukulaliswa esibhedlele kunye nokufa. I-FDA ibongoza uluntu ukuba lugonywe kwaye lufumane i-booster ukuba lufanelekile. Funda ngakumbi malunga nezitofu ezivunyiweyo ze-FDA okanye ezigunyazisiweyo ze-COVID-19.
I-Molnupiravir liyeza elisebenza ngokuzisa iimpazamo kwikhowudi yofuzo yentsholongwane ye-SARS-CoV-2, ethintela intsholongwane ukuba iphinde iphindaphindeke. I-Molnupiravir isetyenziswa njengee-capsules ezine ze-200 milligram ezithathwa ngomlomo rhoqo kwiiyure ezili-12 iintsuku ezintlanu, kwitotali yeecapsules ezingama-40. I-Molnupiravir ayigunyaziswanga ukuba isetyenziswe ngaphezulu kweentsuku ezintlanu zilandelelana.
INTO ONOKUYITHATHA KWELI NQAKU:
- Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.
- It is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in patients hospitalized due to COVID-19 because benefit of treatment has not been observed in people when treatment started after hospitalization due to COVID-19.
- Molnupiravir is limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death,”.
