La I-Arhente yaMayeza yaseYurophu I-Arhente yamayeza yaseYurophu (i-EMA) ithathe inyathelo elibalulekileyo ngokucebisa ukuvunywa kwamayeza amatsha ali-12 kunye nokwandiswa kokusetyenziswa kunyango oluninzi olukhoyo. Ezi zigqibo, ezithathwe kwintlanganiso kaFebruwari yeKomiti yayo yeeMveliso zonyango zokusetyenziswa kwabantu (i-CHMP), zichaphazela uluhlu olubanzi lweemeko, ukusuka izifo ezingaqhelekanga kunye nomhlaza wabantwana kwanomkhuhlane kunye neCovid-19.
Ngaphaya kwempembelelo yobugcisa kuphela, izigqibo ze-CHMP zibonisa umfanekiso apho zombini iindlela zonyango eYurophu njengenkxaso kumazwe anezixhobo ezimbalwa. Phakathi kwamayeza afumene imvume kukho i-vaccine entsha ye-mRNA edibeneyo, unyango lomlomo olulula ukulusebenzisa, kunye namayeza ajolise kwizifo, kude kube ngoku, ebenezinye iindlela ezinqongopheleyo.
Amayeza amatsha: iimvume ezili-12 ezicetywayo
Kwintlanganiso yabo yokugqibela, I-EMA CHMP ucebise imvume ye Amayeza amatsha ali-12Ukongeza, icebisa ukwandisa izalathiso zamanye amayeza amathandathu asele efumaneka kwi-European Union. Olu luhlu luquka unyango lomhlaza, unyango lweengxaki zemithambo-luvo kunye ne-hormone, amayeza ezifo ezingaqhelekanga, kunye nezinye izinto ezifana ne-biosimilar ezijolise ekwandiseni ukhuphiswano kunye nokufikelela.
Phakathi kwezi zinto zintsha, kukho iphakheji ebalulekileyo ye ii-biosimilars ezintandathu, phakathi kwabo ii-insulin ezimbini zesifo seswekileinto efana ne-biosimilar etanercept izifo zokuvuvukala kwamalungu kunye nolusu, esinye sezifo pertuzumab Kumhlaza webele, i-biosimilar ye nguycilizumab Kuboniswe kwiimeko ezahlukeneyo ukusuka kwi-rheumatoid arthritis ukuya kwiingxaki ezinzulu emva konyango CAR-Tkunye i-teriparatide Ezi ndlela zokukhetha zijolise ekuncedeni izigulane ezine-osteoporosis. ukukhuthaza uzinzo olukhulu kwiinkqubo zezempilo zaseYurophu.
Inkqubela phambili kwi-oncology yabantwana kunye nezifo ezingaqhelekanga
Phakathi kwamayeza amatsha, elinye eliye latsala ingqalelo kakhulu leli I-Ojemda (tovorafenib), apho i-CHMP icebise khona imvume yokuthengisa enemiqathangoIjoliswe kwizigulana ezineminyaka eqala kwiinyanga ezintandathu ubudala ezine- i-glioma yabantwana ekumgangatho ophantsi, umhlaza wobuchopho othathwa njengongenabungozi kodwa onokubeka ubomi bomntwana esichengeni kakhulu.
Ukuza kuthi ga ngoku, indlela yokufikelela kolu hlobo lwe-glioma ibixhomekeke kakhulu kwi utyando kunye ne-chemotherapyNangona i-chemotherapy inokusebenza kakuhle kwezinye izigulana, inzuzo yayo idla ngokunqongophala kwaye inxulunyaniswa Iziphumo ebezingalindelekanga ibalulekile, ingakumbi ebuthathaka kubantwana abancinci. Kule meko, u-Ojemda uziveza njenge- ukhetho lokuthathwa ngomlomo veki nganye, yenzelwe ukugubungela uluhlu olubanzi lweemeko ze-glioma zabantwana ezikumgangatho ophantsi.
Olunye uphuhliso olubalulekileyo kwicandelo lezifo ezingaqhelekanga Xolremdi (mavorixafor), efumene uluvo oluhle kwi-CHMP kwi iimeko ezizodwa kunyango lwe isifo se-WHIMLe yimeko engaqhelekanga kakhulu ezuzwe njengelifa apho inkqubo yomzimba yokuzikhusela ingasebenzi kakuhle, nto leyo ebangela ukuba abantu bangakwazi usulelo oluphindaphindayo lweebhaktiriya kunye neentsholongwane Sele kukho umngcipheko okhulayo wezinye iintlobo zomhlaza ezinxulumene neentsholongwane. Eli yeza liboniswa izigulana ezineminyaka eli-12 nangaphezulu.
Kwintsimi ye izifo ezingaqhelekanga ze-endocrineIkomiti ikwanike uvavanyo oluhle kwi Palsonify (paltusotin) ye i-acromegalyEsi sifo singaqhelekanga seehomoni sidla ngokubonakala kubantu abakwiminyaka ephakathi kwaye sibangelwa kukuveliswa kakhulu kwehomoni yokukhula yi-pituitary gland, okunemiphumo efana nokukhula okungaqhelekanga kwezandla, iinyawo kunye neempawu zobuso, kunye neengxaki zentliziyo kunye ne-metabolism.
Iindlela ezintsha zesifo sikaParkinson, i-urticaria engapheliyo, kunye nezinye izifo
I-CHMP ikhuphe uluvo oluhle malunga U-Onerji (i-levodopa/i-carbidopa), iyeza elenzelwe abantu abadala abanesifo sikaParkinson esiphambiliEsi sifo siqhubekekayo se-neurodegenerative sibonakaliswa kukungcangcazela, ukuqina kwemisipha, ukucotha kokuhamba, kunye neengxaki zokulinganisela, kwaye sidla ngokufuna uhlengahlengiso oluntsonkothileyo lonyango njengoko siqhubeka. Indlela entsha ye-Onerji ijonge ukuphucula ulawulo lweempawu zemoto kwizigaba eziphambili zesifo.
Kwicandelo lezifo zesikhumba kunye nezifo zomzimba, ikomiti ivumile Rhapsido (remibrutinib) yonyango lwe- i-urticaria engapheliyo engaqhelekangaLe meko ibandakanya ukuqhambuka okuqhubekayo kwe-hives kunye nokurhawuzelelwa ngaphandle kwesizathu esicacileyo. Kwabo bangasabeli ngokwaneleyo kwi-antihistamines eqhelekileyo, ukufumaneka kweendlela ezintsha ezifana neRhapside kunokubonisa ukuphucuka okukhulu ekulawuleni iimpawu.
Kunye nala mayeza, i-EMA ikwacebise ukuthengiswa mCombriax, ichazwa njenge isitofu sokuqala se-RNA esidityanisiweyo ngokuchasene nomkhuhlane wexesha elithile kunye neCovid-19. Yenzelwe abantu abangaphezu kweminyaka engama-50 ubudala, iqela apho zombini ezi zifo zibangela ukugula okunzulu kunye neengxaki zokuphefumla.
Le arhente iphawula ukuba, nangona kukho utshintsho kwisigaba sobhubhane, iCovid-19 iyaqhubeka nokufaka uxinzelelo olukhulu kwimpilo yoluntu: I-WHO ibhale amatyala angaphezu kwezigidi ezingama-281 kummandla waseYurophu kude kube nguFebruwari 2026. Ngaxeshanye, umkhuhlane wonyaka iyaqhubeka ibangela minyaka le de Amatyala aneempawu ezizizigidi ezingama-50 kwiCandelo lezoQoqosho laseYurophu. Ingcamango yale ntsholongwane idibeneyo kukwenza kube lula ukuthintela, okwenza kube lula kubantu abasengozini ukuzikhusela kuzo zombini ezi zifo ngomjovo omnye.
Inkxaso kumazwe anengeniso ephantsi: i-acoziborol yesigulo sokulala
Ukongeza kwizigqibo ezichaphazela ngokuthe ngqo imakethi yaseYurophu, ikomiti ikhuphe uluvo oluhle malunga I-Acoziborole Winthrop (acoziborol), a unyango lomlomo olunedosi enye kwi I-trypanosomiasis yabantu baseAfrika, eyaziwa kakhulu ngokuba sisifo sokulala, esibangelwa yi-parasite Trypanosoma brucei gambienseEli yeza lenzelwe ukusetyenziswa ngaphandle kweManyano yaseYurophu kwaye livavanyiwe kusetyenziswa inkqubo i-EU-M4All.
Inkqubo ye-EU-M4All ivumela i-EMA ukuba ifake isandla kwizigqibo zolawulo amazwe anengeniso ephantsi kunye nephakathiukukhawulezisa ukufikelela kumayeza abalulekileyo kwiindawo ezinqongopheleyo kwezixhobo. Kwimeko ye-Acoziborole Winthrop, injongo kukwenza kube lula kakhulu unyango kuzo zombini izigaba zokuqala nezesibini zesigulo sokulala, ebezifuna iindlela zonyango ezintsonkothileyo, kwaye ngamanye amaxesha, ukuhlala esibhedlele ixesha elide.
La I-African trypanosomiasis (isifo saseGambia) Idluliselwa ngokulunywa ziimpukane ezineentsholongwane. Kwiintsuku ezimbalwa zokuqala emva kokosuleleka, umkhuhlane, intloko ebuhlungu, kunye nokudumba kolusu kunokubonakala, kodwa ukuba ukosuleleka kuyaqhubeka ngaphandle konyango, ekugqibeleni kuyachaphazela Inkqubo ye-nerve ephakathikunye nokuphazamiseka kokulala, utshintsho kwindlela yokuziphatha, kwaye ekugqibeleni, umngcipheko wokufa. Nangona amaphulo okulawula enciphise kakhulu inani lamatyala—okwangoku angaphantsi kwe-1.000 axelwa minyaka le e-Afrika—esi sifo sisenokubulala ukuba asinyangwa.
I-Acoziborole Winthrop iboniswe kwi abantu abadala kunye nabakwishumi elivisayo ukususela kwiminyaka eli-12 ubudala ezinobunzima obuyi-40 kg ubuncinane, ezigubungela zombini izigaba zokuqala nezesibini zosulelo lweTrypanosoma brucei gambiense. Inyaniso yokuba inikwa ngedosi enye yomlomo inokwenza kube lula ukuyisebenzisa kwiindawo zasemaphandleni okanye kwiindawo ezineziseko zempilo ezincinci, apho ukujonga unyango olude kunzima kakhulu.
Amayeza alahliweyo kunye nokurhoxiswa kwesicelo
Ayizizo zonke izindululo eziqwalaselwe yikomiti ezamkelweyo. I-CHMP icebise yeka imvume yokuthengisa de UDaybu (trophinitide), iyeza elenzelwe Isifo seRettEsi sifo semfuza sibonakaliswa kukukhubazeka kwengqondo, ukulahleka kolwimi, kunye nokubuyela umva kwezakhono phakathi kweenyanga ezi-6 ukuya kwezi-18 ubudala. Ngokutsho kwe-EMA, ubungqina obukhoyo abubonisanga ukulinganisela okuhle phakathi kweenzuzo kunye nomngcipheko.
Ikwafumene uphononongo olubi. Amayeza e-Iloperidone Vanda (iloperidone), eyayicingelwe ukuba ingasetyenziswa kunyango lwe- isifo sengqondo kunye neziqendu ezingaqhelekanga okanye ezixutyiweyo ezinxulumene UkuxhuzulaKwakhona, ikomiti igqibe kwelokuba idatha enikiweyo ayanelanga ukuxhasa ukugunyaziswa kwayo kwiManyano yaseYurophu phantsi kweemeko eziceliweyo.
Ngaxeshanye, kuye kwaxelwa ukuba ukurhoxiswa kwesicelo sokuqala sokugunyaziswa de I-Emerald (sasanlimab), iyeza elisenzelwa ukuphuhliswa umhlaza wesinyiUkurhoxiswa kuthetha ukuba umfaki-sicelo ugqibe ekubeni angaqhubeki nenkqubo yovavanyo ngeli xesha, mhlawumbi elinde idatha entsha okanye ukuvavanywa kwakhona kwesicwangciso sophuhliso lweklinikhi.
Ukwandiswa kwezalathisi zamayeza asele egunyazisiwe
Ukongeza kumayeza amatsha, i-CHMP icebise ukwandisa izikhokelo zonyango de amayeza amathandathu eyayisele inemvume kwiManyano yaseYurophu. Phakathi kwazo, olunye lolona tshintsho luphawulekayo lolo Dupixent (i-dupilumab), eyandisa ukusetyenziswa kwayo iye kwi- I-urticaria engapheliyo engaqhelekanga kubantwana abaneminyaka emi-2 ukuya kweli-11 ubudalaNgesi sigqibo, uba unyango lokuqala olufumanekayo lwebhayoloji kwizigulane zabantwana abangaphantsi kweminyaka eli-12 ubudala abanale sifo.
Ukwandiswa kweDupixent kubonisa ukomelela okukhulu kwezixhobo zonyango kwiintsana, ingakumbi kwiintsapho ezinabantwana abangaphenduliyo kunyango oluqhelekileyo. I-urticaria engapheliyo ebantwaneni inokuba yingozi kakhulu, kwaye xa kungekho zindlela zijoliswe kuzo, umda we-maneuver wawumncinane kakhulu kude kube ngoku.
Olunye utshintsho olufanelekileyo luyenzeka nge IJorveza (budesonide), nto leyo eyandisa uphawu lwayo kwi i-esofagitis eosinofÃlica kwizigulane eziphakathi kweminyaka emi-2 ukuya kweli-17 ubudala. Le meko ingaqhelekanga yokudumba komphimbo inokubangela ubunzima bokuginya, iintlungu zesifuba, kunye neengxaki zokutya, ingakumbi kubantwana abancinci. Indlela ethile kaJorveza yokulungiselela abantwana ijolise ekwenzeni lula ukunikezelwa kunye nokuphucula ukunamathela kunyango.
Ngaphezu koko, ikomiti icebise izongezo ezine ezongezelelweyo zezibonakaliso amayeza omhlaza aziwayo kunye ne-immunomodulators: Isitshixo, Olumiant, Scemblix y UStenaraNangona iinkcukacha ezithile zolwandiso ngalunye zingachazwanga kwingxelo, ezi zigqibo zihlala ziphendula kubungqina obutsha obubonisa ukuba buluncedo ku ezinye iintlobo zeethumba, izifo ezivuthayo okanye amaqela amancinci ezigulana ezazingabandakanywanga ngaphambili kwiphepha ledatha yobugcisa.
Xa zizonke, ezi zandiso zivumela unyango olwalukade lulinganiselwe kwiimpawu ezithile ukuba lunikwe umntu inani elikhulu lezigulane ngaphakathi kwe-EU, besebenzisa amava aqokelelweyo kunye nedatha yokhuseleko kunye nokusebenza kakuhle efunyenwe emva kokusetyenziswa kwayo kwizenzo zonyango.
Iphakheji yesigqibo se-CHMP sikaFebruwari ibonisa intshukumo ebanzi apho I-EMA iqinisa indima yayo yokulawula eYurophu nakwiindawo ezinqongopheleyo kwezixhobo. Ingcebiso yamayeza amatsha ali-12, ukuvunywa kwe-mRNA vaccine edibeneyo yokulwa nomkhuhlane kunye ne-Covid-19, ukufika kweendlela zonyango zomhlaza wabantwana kunye nezifo ezingaqhelekanga, kunye nokwandiswa kweempawu zamayeza aphambili amaninzi kunye nokungeniswa kwe-biosimilar, kudala imeko apho iindlela zonyango zanda kwizigidi zezigulane, zihlala ziphantsi kwengcamango yokuvavanya ngokungqongqo ibhalansi phakathi kweenzuzo kunye neengozi.
