
eculisumab

soliris enna brand naamatthil vilkkunna ikkulisumab, paroxismal noctornal haemoglobinuria (pnh), ettipikkal haemolitic yuramik syndrome (ahus), generalised mayasteniya gravis, neuromyelitis opttikka enniva chikilsikkaan upayogikkunna oru punasamyojitha manushyavalkkaricha monoclonal antibodyaanu. pnh ullavaril, ithu chuvanna rakthaanukkalude nashavum rakthappakarchayude aavasyakathayum kuraykkunnu, pakshe maranasaadhyathaye baadhikkunnillenn thonnunnu. oro upayogathinum amgeekaricha aadyathe marunnaan eculisumab, cheria pareekshanangalude adisthaanathil athinte amgeekaaram labhichu. intravinus infusion vazhiyaan ithu nalkunnathu.
paarshwafalangalil meninchococcal anubaadhaykkulla apakadasaadhyatha ulppedunnu, ithu aalukalude kaunsiling ulkkollunnathum avarkk prathirodha kuthivayppu nalkiyittundennu urappakkunnathum ulppedunna apakadasaadhyatha vilayiruthalum laghookarana thanthravum pinthudarunnavarkku maathrame nirddeshikkaavoo. oru terminal compliment inhibittaraayi pravartthikkunna oru manushyavalkkaricha monoclonal antibodiyaanithu.
alaksan farmaceuticals aanu ithu vikasippikkukayum nirmmikkukayum vipananam cheyyukayum cheiyunnathu.
medical upayogangal.
ettipikkal haemolitic euremic syndrome (aahs), paroxismal noctornal haemoglobinuria (pnh) enniva chikilsikkaan eculisumab upayogikkunnu. pnh ulla aalukalkk, ithu jeevithanilavaram mechappeduthukayum rakthappakarchayude aavasyakatha kuraykkukayum cheiyunnu, pakshe maranasaadhyathaye baadhikkunnillenn thonnunnu. raktham kattapidikkuka, myelodysplastic syndrome, acute myelogenous leukemia, allengil applaastik anaemiya ennivayude apakadasaadhyathayil ithu maattam varuthunnillennu thonnunnu. aanti-akwaporin-4 (eiii. keey. pii. 4) antibody positteev aaya muthirnnavaril neuromyelitis opttikka spectrum desorder chikilsikkaanum eculisumab upayogikkunnu.
rogaprathirodha samvidaanathinte apoorva janithaka thakararaya chapple syndrome ennum ariyappedunna sidi55 kuravinulla chikilsayaayi eculisumab paryavekshanam cheythittundu. anukambayodeyulla oof-label upayogathinulla amgeekaarathode, kurolap sahapravarthakarum eee marunnu upayogichu rogikale chikilsikkukayum 18 maasa kaalayalavil ithinu positteev klinikkal, laborattari phalangal undaakumenn kandethukayum cheythu.
prathikoola phalangal.
eculisumab meninchococcal anubaadhayude apakadasaadhyathaykkaayi oru black boxes munnariyipp vahikkunnu, koodaathe eph. dii. eiii. kku aavashyamaaya apakadasaadhyatha vilayiruthalum laghookarana thanthravum pinthudarunna doctormark maathrame ithu nirddeshikkaan kazhiyoo, athil doctormar avar nirddeshikkunna aalukalude kaunsiling ulppedunnu marunnu, avarkk vidyaabhyaasa saamagrikal nalkuka, avarkk prathirodha kuthivayppu nalkiyittundennu urappaakkuka, ivayellaam rekhappeduthanam.
eculisumab terminal compliment aakttiveshane thadayunnu, athinaal aalukale encapsulated jeevikalumaayulla anubaadhaykk irayaakkunnu. eculisumab sweekarichavaril jeevanu bheeshaniyum maarakavumaya meninchococcal anubadhakal undaayittund. eculisumab sweekarikkunna aalukalkk aakramanathmaka meninchococcal rogam varaanulla saadhyatha 2,000 madangu kooduthalaanu. meninchococcal anubaadhayude vardhicha apakadasaadhyatha kaaranam, eculisumab sweekarikkunnathinu kuranjathu randaazhcha munbengilum meninchococcal prathirodha kuthivayppu shupaarsha cheiyunnu, eculisumab therapy vaikippikkunnathinulla apakadasadhyathakal meninchococcal anubadha undakanulla saadhyathaye marikadakkunnillenkil, eee saahacharyathil meninchococcal vaxine ethrayum vegam nalkanam. eculisumab sweekarikkunna aalukalkk eiii, sii, dablyu, vaii konjugettu meninchococcal vaxine serogroup bii meninchococcal vaxine shupaarsha cheiyunnu. shupaarsha cheyyappedunna prathirodha kuthivayppukal sweekarikkunnathu ellah meninchococcal anubaadhakalum, prathyekichu groupable allaathavayil ninnu thadayilla. meninchiditis. prathirodha kuthivayppu nadathiyittum eculisumab aakramanathmaka meninchococcal rogathinu kaaranamaayenn 2017 ll vyakthamaayi, kaaranam ithu aakramanathmaka rogangalil ninnu samrakshikkaanulla antimeninchokokkal aantibodikalude kazhivine thadassappeduthunnu.
chuvanna rakthaanukkalude naashatthil ninnu undaakunna gurutharamaaya vilarchayekkurichum cheria rakthakkuzhalukalil raktham kattapidikkunna gurutharamaaya kesukalekkurichum marunninte labelukalil munnariyippukal undu.
thalavedana valare saadhaaranamaaya prathikoola falangalaanu, ithu marunnu kazhikkunna 10 sathamaanathiladhikam aalukalil sambhavikkunnu.
anubadhakal (pneumonia, mukalile shwaasakosha anubadha, jaladosham, moothranaaliyile anubadha), velutha rakthaanukkalude nashtam, anaphylactic prathikaranam, hypersensitivity prathikaranam, vishapp nashtappedal, vishaadavum uthkandayum polulla maanasikaavasthayile mattangal, ikkiliyo maravippo, mangiya kazhcha, vertigo, cheviyil shabdamundaakal, hridayamidippu, uyarnna rakthasammardham, thaazhnna rakthasammardham, rakthakkuzhalukalude kedupaadukal, perittonitis, malabandham, vayaruvedana, vayaruvedana, chorichil, charmmatthil chorichil, vardhicha vearp, charmmathinu thaazheyulla cheria rakthasraavam, charmmatthil chuvapp, theneechakkoodukal, peshivedana, asthi vedana, puram vedana, kazhuthu vedana, veekkam, sandhikalkk kedupaadukal, moothrathil kedupaadukal, vrukkayude vedana, nenjuvedana, nenjuvedana, uyarnna nenjuvedana, uyarnna nenjuvedana, uyar
farmacology.
eculisumab terminal compliment ghadakam 5 allengil sii 5-maayi prathyekamaayi bandhippikkunnu, ithu compliment cascadinte avasana ghattathil pravartthikkunnu. sajeevamaakumbol, sii5 hoost cellukale sajeevamakkunnathil earppedunnu, athuvazhi proo-inflammatory rogaprathirodha koshangale aakarshikkunnu, athesamayam sushirangalude roopeekaranam uthejippichu koshangale nasippikkunnu. eee ghattathil compliment cascade thadayunnathiloode, proximal compliment sisttathinte saadhaarana, roga prathirodha pravartthanangal pradhaanamaayum samrakshikkappedunnu, athesamayam veekkavum koshanashavum prothsaahippikkunna sii5-nte gunangal thadassappedunnu.
prothrombotic, proinflammatory gunangalulla sakthamaaya anaphylatoxin aaya sii5eiii aayi sii5 convertase vazhi sii5 villaline eculisumab thadayunnu, koodaathe sii5babaiii, ithu terminal compliment complexes sii5babaiii-9 roopeekarikkunnu, ithinu prothrombotic, proinflammatory efakttukalum undu. sii5eiii, sii5babaiii-9 enniva pnhinteyum ahasinteyum savisheshathakalaaya pooraka-madhyastha sambhavangalkk kaaranamaakunnu.
cheria pepttaidukalum amino aasidukalum uthpaadippikkunnathinaayi aantibodikale pilarthunna lysosomal ensimeukal vazhiyaan eculisumabinte metabolism sambhavikkunnathenn karuthappedunnu. manushyaril eculisumabinte vitharanathinte alavu plasmayude alavinte alavu kanakkakkunnu.
rasathanthram.
compliment protein sii5-nethiraaya oru punasamyojippicha manushyavalkkaricha monoclonal antibodyaanu ikkulisumab. manushya sthiramaaya pradeshangalum manushya chattakkoodile prakashavum kanatha shringhala variable pradeshangalilum graaft cheytha murine komplimentaaritti nirnnayikkunna pradeshangalum ulkkollunna oru immunoglobulin jii-kappa (aijike) aanu ithu. eee samyukthathil rund 448-amino assid hevi cheyinukalum rund 214-amino assid laitt cheyinukalum adangiyirikkunnu, ekadesham 148 kilodalton (keey. dii. eiii) tanmatra bhaaramund.
samoohavum samskaaravum.
niyamaparamaaya padavi.
pnh chikilsaykkaayi 2007 maarchil us phudu aandu drugg administration (fda) ikkulisumabinu amgeekaaram nalki. 2017 vare eculisumabinu exclusivity avakaashamund, ithu 2017 vare malsarathil ninnu samrakshikkunnu.
2011 septambaril eph. dii. eiii. ithu ausinte chikilsaykkaayi amgeekarichappol, athu oru anatha marunnayi prakhyaapichu.
2011leeii eph. dii. eiii amgeekaaram 17 perudeyum 20 perudeyum rund cheria pareekshanangale adisthaanamaakkiyullathaayinu.
2007 juunil pnh chikilsaykkum 2011 novemberil ahaz chikilsaykkum europian medisins ejansi ithu amgeekarichu.
2009ll pnh chikilsikkunnathinaayi health canada ithu amgeekarikkukayum 2013ll ahaz chikilsikkunnathinulla eaka marunnayum ithu amgeekarikkukayum cheythu.
prevent trialinte phalangalude adisthaanathil 2019 ll eiii. kyu. pii. 4 + enn. emm. oo. kku fda eculisumab amgeekarichu.
saambathikashaasthram.
paroxismal noctornal haemoglobinuria ullavarude aayurdairkhyam mechappeduthunnathinna eculisumab therapy aparyaapthamaanennu kaanikkunnathin mathiyaya thelivukalillennum chelavu-falaprapti moshamaanennum 2014 leeii oru patanam kaanikkunnu.
2010ll, alexian solirisinu lokathile ettavum chelaveria marunnayum amerikkayil prathivarsham ekadesham 409,500 dollar (2010), yukeyil nadannukondirikkunna chikilsaykkaayi prathivarsham 430,000 euro, kaanadayil prathivarsham 500,000 dollar (2014) enninganeyulla vilayullathum aayirunnu. 2021ll vilppanayil solirikal srishtichu.
2013 eprililum meyy maasathilum beljiyathil oru vivaadam udaleduthu, soliris valare chelaveriyathukondu ezhu vayassulla aankuttiyude chikilsaykku sarkkar panam nalkaan visammathichathayi maadyamangal velippeduthi. aankuttiyude marunnin randaazhcha koodumbol 9,000 euroyaanu vila. alexonil jolie cheiyunna oru public relations ejansi atharamoru katha tirayukayum marunninte vila thirichadaykkaan sarkkaarukalkk mail sammarddam cheluthunnathinaayi kuttiyude maathaapithaakkale avarude katha maadyamangalodu ariyikkaan sahayikkukayum cheythathayi reportund. sarkkaarine blackmayil cheyyaan kambani sramikkunnuvennu niravadhi raashtreeyakkaar prasthavikkukayum alaksan athu nishedhikkukayum cheythu. 2013 meyy 7-nakam, 2013 juulai muthal marunninte vila thirichadaykkaan sarkkaarumaayi oru karaarilethiyirunnu.
2013 desemberil, nyoosilandile sarkkar farmaceutical vaangunna pharmacic, prathi vyakthikk prathivarsham 670,000 dollar (590,000 us dollar) vila kuraykkaan alaksan visammathichathinethudarn marunnin subsidy nalkaanulla nirddesham nirasikkukayum faarmaasinte saambathika vishakalanam marunnu subsidy nalkaan paryapthamaaya chelavu varunnathinu munbu vila pakuthiyaayi kuraykkanamennu nirnnayikkukayum cheythu. nyoosilandile pnh ulla palareyum faarmasinte theerumaanam aswastharaakkiyengilum marunnu kuranja vilaykk labhyamakkiyaal pinneedulla theeyathiyil theerumaanam avalokanam cheiyunnathine farmac thallikkalanjitilla.
2014 desemberil kaanadayile ontaariyo pravishya sarkkar, asusine chikilsikkaan health canada amgeekaricha eaka marunnaaya nirmmathaavumaayi vila charcha cheythu. oro kesilum aalukalkk "anukambayude adisthaanathil" apekshikkaam, udaaharanathinu jeevan, avayavangal allengil avayavangalkk bheeshaniyaakunna sankeernnatha kaaranam adiyanthiramaayi ashupathriyil praveshippikkappetta vyakthikal."2011 ll pravishya pradhaanamantrimaar nadatthiya bulk-bye karaariloode mattoru apoorva rogamaaya paroxismal noctornal haemoglobinooriyayude (pnh) chikilsaykkaayi ontaariyo sarkkar ithinakam dhanasahayam nalkiyirunnu."
2015 februvariyil, kaanadayude marunnu-vila regulator "ettavum uyarnna anthaaraashtra vila thaarathamyathinu" (hipsey) keezhil anuvadaneeyamaaya vila paridhi alaksan kaviyunnuvennu aaropich solirisilekku oru vaadam kelkkunna apoorva nadapadi sweekarichu. 2015 juunil, canaden pettant niyamathinu keezhilulla pettant nediya medisin prais review board (pii. emm. pii. aarr. bii) aropanangal parishodhikkunnathinaayi ontaariyoyile ottavayil praadhamika vaadam kettu. ontaariyo aasthaanamaayulla alaksan kaanadayile vogan presidentum general maanejarumaaya joonn haslamine prathikarichavaril oralaayi thiranjedutthu. lokathil mattevidathekkaalum kooduthal, alaksan prathivarsham oraalkk 700,000 dollar eedaakkunnu. alaksan eee avakaashavaadam nishedhikkunnu. kaanadayil "pravishya marunnu padhathikal ithinakam thanne avar parirakshikkuna pala rogikalkkum solirisinu rahasya kizhivukal charcha cheythittundu."
2015 leeii kanakkanusarichu, pnhile eculisumab 1.13 adhika aayurvarshangalumaayum 2.45 gunanilavaaramulla aayurvarshangalumaayum bandhappettirikkumbol, uyarnna vardhichuvarunna chelavum ($5.24 dasalaksham vare) ganyamaaya avasarachelavum undaayittund. 2014 leeii oru canadian patanam chikilsayiloode nediya oro jeevita varshathinum 4.62 dasalaksham dollar (us $4,571,564) gunanilavaaram krameekaricha jeevita varshathinu 2.13 dasalaksham dollar (us $2,112,398) kanakkakki."oro varshavum vardhichuvarunna chelavu, oro kalikkum yathaakramam 4.62 dasalaksham dollar 2.13 dasalaksham dollarumaan. sthaapithamaaya paridhi adisthaanamaakki, eculisumab funting avasara chelavu oru rogikk dhanasahayam labhikkuna 102.3 kizhivu callis aanu."
2015 aayappozhekkum, eculisumab polulla anatha marunnukalude uyarnna vila gaveshanam, vikasanam, ulppaadana chelavu ennivayumaayi bandhappettathallenn vyavasaya vishakalana vidagtharum academic gaveshakarum sammathichu avayude vila ekapaksheeyavum parambaraagatha marunnukalekkaal laabhakaravumaan.
brazilian saarvathrika aarogya parirakshaa samvidaanam ellah varshavum pouranmaarkkaayi ithu nalkiyittundu. thudakkathil sarkkaarinethire kesedukkukayum chikilsaykkulla avakasham aavasyappedukayum cheythaanu rogikalkku ithu labhichathu. 2016ll 364 rogikale chikilsikkunnathinaayi 625 dasalaksham raise (akkaalat ekadesham 178 dasalaksham dollar) enna kanakkumaayi judicial maarggathiloode systethinu ettavum valia chelavu varuthiya marunnaanith, ennaal ellah sisttam pathiv marunnukalum ennumbol ithu randaamathethaanu, ettavum valia chelavu sophosbuvir aayirunnu. brazeelile solirisinte pettant takarkkaan brazeelile supreme kodathi 2018 eprilil vidhichu, ithu praadeshikamaayi ulppaadippikkaan praapthamakki. 2018 desemberil ithu pothujanaarogya samvidaanathil ulppeduthi.
biosemiller malsaram.
amjen vikasippichedutha oru biosemiller yuu-yill praveshikkunnathil ninnu thadayunnu.ezz. 2025 vare vipani.
branded elisaria enna biosemiller pathipp russiayil labhyamaan.
2023 februvari 23 nuu, europian medisins ejansiyude (iii. emm. eiii) manushya upayogathinulla aushadha uthppannangalkkayulla samiti (ch. emm. pii) oru nalla abhiprayam sweekarichu, paroxismal noctornal haemoglobinuriyayile muthirnnavarudeyum kuttikaludeyum chikilsaykkaayi uddeshichittulla aushadha ulppannamaaya beckemvinu oru vipanana amgeekaaram nalkanamennu shupaarsha cheythu. eee aushadha uthppannathinulla apekshakan amjen teknolaji (ireland) paridhiyillaattha kambaniyaanu. biosemiller aushadha ulppannamaanu bekemvu. 2007 juun 20 nuu europian yooniyanil amgeekaricha reference ulppannamaaya solirisumaayi (eculisumab) ithu valare saamyamullathaan. beckemvinu solirisumaayi thaarathamyappeduthaavunna gunanilavaaravum surakshyum falapraptiyum undennu daatta kaanikkunnu. 2023 eprilil europian yooniyanil medical upayogathinaayi bekkemv amgeekarichu.
2023 meyy maasathil europian yooniyanil medical upayogathinaayi episcly amgeekarichu.

