Kimyrsa (oritavancin) Tshaj Tawm: Kev Kho Mob Ntawm Cov Kab Mob Ntawm Cov Kab Mob Thiab Cov Kab Mob Ntawm Daim tawv nqaij (ABSSSI)!

Melinta Therapeutics tsis ntev los no tshaj tawm Kimyrsa (oritavancin) hauv Asmeskas kev lag luam, lipoglycopeptide tshuaj tua kab mob siv los kho cov kab mob rhiab ntawm cov kab mob Gram-positive (suav nrog methicillin-resistant Staphylococcus aureus [MRSA]) hauv cov neeg laus uas muaj kab mob tawv nqaij thiab tawv nqaij. tus kab mob kis tus kab mob (ABSSSI). Kimyrsa tau pom zoo thaum Lub Peb Hlis 2021. Los ntawm ib zaug, ib teev, 1200mg infusion, ua tiav kev kho ABSSI tuaj yeem muab tau.

Kimyrsa yog ib koob tshuaj ntev ua rau lipoglycopeptide tshuaj tua kab mob nrog rau cov tshuaj tua kab mob sai thiab tau siv los kho ABSSI rau cov neeg laus tshwm sim los ntawm cov kab mob Gram-positive (suav nrog MRSA).

Kimyrsa yog thawj cov tshuaj oritavancin yuav tsum tau txhaj tshuaj hauv 1 teev. Nws suav nrog 1200mg vial nrog 0.9% Sodium Chloride Injection (NS) thiab 5% Dextrose Sterile Water (D5W). Kimyrsa, raws li cov khoom lag luam oritavancin, muaj peb yam kab mob tua kab mob: txwv tsis pub transpeptide, txwv tsis pub transglycosylation thiab rhuav tshem cov cell membrane ncaj ncees.

Christine Ann Miller, Thawj Tswj Hwm thiab CEO ntawm Melinta tau hais tias: "Melinta tau mob siab rau nthuav peb cov peev txheej los muab kev kho mob tshiab rau cov neeg mob uas tsis xav tau kev pab. Kev tshaj tawm Kimyrsa qhia qhov kev cog lus no. Tam sim no, hauv kev kho mob ntawm ABSSSI, cov kws kho mob thiab cov neeg mob yuav muaj qhov tshiab, ib teev ib zaug rau lwm txoj hauv kev los hloov cov txheej txheem niaj hnub siv ntau koob. Peb lub zeem muag yog tias txhua tus neeg mob uas xav tau peb cov tshuaj yuav tuaj yeem tau txais kev kho mob, thiab peb ntseeg tias qhov tshuaj tseem ceeb tshiab no yuav yog rau cov neeg mob muab kev hloov pauv tau yooj yim dua thiab yooj yim dua ntawm kev tau txais kev kho mob ABSSI sab nraum lub tsev kho mob."

Oritavancin qauv qauv

ABSSI cuam tshuam txog kwv yees li 14 lab tus neeg mob hauv Tebchaws Meskas txhua xyoo, thiab ntau dua 3 lab tus mus ntsib chav kho mob xwm txheej txhua xyoo, ua rau nws yog yim qhov laj thawj feem ntau rau kev nkag mus rau tsev kho mob xwm txheej ceev. ABSSI ua rau $ 4 nphom poob rau Asmeskas tsev kho mob txhua xyoo, thiab qhov nruab nrab ntev ntawm kev nyob hauv tsev kho mob ABSSI cov neeg mob yog 4.0 hnub.

Kimyrsa yog qhov kev xaiv kho tshiab tseem ceeb uas yuav muab cov kws kho mob hloov pauv yooj yim los kho ABSSI cov neeg mob hauv ntau yam kev saib xyuas yam tsis tas yuav tsum tau mus pw hauv tsev kho mob. Kev siv tshuaj tua kab mob ntev ua ib zaug ib zaug, xws li Kimyrsa, yuav muaj txiaj ntsig tshwj xeeb rau cov neeg mob uas tsis muaj kev txhawb nqa lossis cov peev txheej kom mob ntxiv rau ntau txoj kev tswj ntshav.

Melinta Tus Thawj Saib Xyuas Kev Lag Luam John Harlow tau hais tias:" Kev tso tawm Kimyrsa tau teb ncaj qha rau kev thov ntawm cov kws kho mob hauv zej zog kom muab cov tshuaj oritavancin nrog lub sijhawm siv tshuaj luv, ntxiv cov tshuaj ntxiv, thiab txo qhov ntim cov tshuaj. Raws li qhov khoom thib ob ntawm oritavancin franchise, Peb pab pawg lag luam muaj kev paub ntau yam hauv kev pabcuam kev lag luam, thiab peb zoo siab los pib qhia qhov kev kho tshiab no rau peb cov neeg siv khoom."

Qhov ua tau zoo thiab nyab xeeb ntawm Kimyrsa tau lees paub hauv kev sim tshuaj SOLO ntawm lwm cov tshuaj oritavancin Orbactiv. SOLO qhov kev sim yog qhov kev xaiv, ob-qhov muag tsis pom, ntau qhov chaw tshawb fawb uas tshuaj xyuas qhov ua tau zoo ntawm kev txhaj tshuaj ib leeg ntawm 1200 mg oritavancin thiab vancomycin (vancomycin) ob zaug ib hnub hauv kev kho mob ABSSI hauv xyoo 1987 cov neeg laus thiab ntsuas qhov loj tshaj MRSA Ib ntawm pab pawg neeg mob sib kis (405 tus neeg mob). Cov kev sim no qhia tias, rau thawj qhov kawg thiab theem nrab, ib qho 1200 mg tso rau hauv oritavancin txoj kev tso ntshav yog sib npaug rau vancomycin (1 g lossis 15 mg/kg) ob zaug ib hnub rau 7-10 hnub.

Kimyrsa' kev pom zoo yog ua raws cov txiaj ntsig ntawm kev qhib-daim ntawv lo, ntau lub chaw, chaw muag tshuaj pharmacokinetic (PK). Txoj kev tshawb fawb no piv cov txiaj ntsig ntawm Kimyrsa txoj kev tso ntshav rau 1 teev (N=50) thiab Orbactiv cov tshuaj txhaj tshuaj rau 3 teev (N=52) hauv kev kho cov neeg laus nrog ABSSI. Cov txiaj ntsig tau lees paub tias Kimyrsa muaj qhov ua tau zoo ib yam li Orbactiv thiab muaj kev nyab xeeb zoo.

Kimyrsa yog cov khoom lag luam oritavancin nrog lub sijhawm tso ntshav luv. Cov kev tshawb fawb saum toj no txhawb nqa Kimyrsa' lub sijhawm luv luv thiab txo qis qhov ntim cov ntshav kom muab kev ua tau zoo thiab nyab xeeb ntawm kev kho oritavancin. Nrog cov yam ntxwv no, Kimyrsa tuaj yeem txhim kho tus neeg mob ntxiv' kev kho mob thiab txhim kho kev ua haujlwm tau zoo hauv kev kho mob