Daawaynta Dareen-ka-qabashada Kelyaha Cusub ee Ku-tallaalidda

Siideynta Xorta ah ee HAYS 6 | eTurboNews | eTN
Written by Linda Hohnholz

Hansa Biopharma AB maanta waxay ku dhawaaqday in bukaankii ugu horreeyay ee ku jira summadeeda furan ee US, randomized, tijaabada muhiimka ah ee la kontoroolo ("ConfIdeS") laga diiwaan geliyay Xarunta Caafimaadka ee Jaamacadda Columbia, New York. Tijaabada ConfIdeS waxay qiimaynaysaa imlifidase sida daawaynta miyir-qabka ee suurtogalka ah si ay awood ugu siiso ku-tallaalidda kelyaha ee bukaannada aadka u dareensan ee sugaya kelyaha deeqaha ee dhintay iyada oo loo marayo nidaamka qoondaynta kelyaha ee Maraykanka.

Tijaabada ayaa la filayaa in ay kala soocto 64 bukaanjiif ah oo dareenkoodu sareeyo oo leh cPRA oo ah ≥99.9%, taas oo ka dhigan qayb ka mid ah bukaanada aadka u dareensan ee sii wada in ay sii liidato in kasta oo la kala hormarinayo nidaamka qoondaynta kelyaha ee Maraykanka. Marka xubin ku-deeqaha la helo oo is-garab togan lala yeesho qaataha loogu talagalay ay tilmaanto in xubinta aysan ku habboonayn, bukaan-socodka ayaa loo kala sooci doonaa si ay u baabi'iso daawaynta dareen-celinta ama cudud kontorool oo heli doonta heerka daryeelka (sida sugitaanka daryeel la jaan qaadi kara) Kelyaha oo bixiya ama la siinayo daawaynta dareen-celinta tijaabada ah). Barta ugu dambeysa ee daraasadda ee imlifidase si loo qiimeeyo faa'iidada beerista bukaannada aadka u dareensan waa shaqada kelyaha tallaalka ee bilaha 12, oo lagu cabbiray eGFR (qiyaastii Glomerular Filtration Rate).

Hadafka tijaabada ConfIdeS waxay la socdaan "Hormarinta Caafimaadka Kelyaha Mareykanka" ("AAKH") Amarka Fulinta ee Mareykanka yoolalka: (360) yaraynta halista kelyaha oo shaqayn waayey; (1) hagaajinta galaangalka iyo tayada ikhtiyaarada daawaynta ee qofka ku salaysan; iyo (6) kordhinta helitaanka kelyaha beddelka, iyadoo labada dambe ay si toos ah ugu xidhan yihiin balaadhinta tallaalka.

Robert A. Montgomery, MD, Professor Qalliinka iyo Agaasimaha, NYU Langone Transplant Institute ee Magaalada New York, ayaa loo magacaabay Baaraha Iskuduwaha Qaranka ee tijaabada ConfIdeS. Tijaabooyinku waxay ku qori doonaan bukaanada 12 ilaa 15 xarumaha tallaalka ee hormuudka ka ah Maraykanka

Dhamaystirka diiwaangelinta tijaabada ayaa la filayaa qaybta labaad ee 2022, iyada oo 12 bilood oo daraasad dabagal ah la filayo in la dhammeeyo qaybta labaad ee 2023. Natiijooyinka tijaabadan muhiimka ah ayaa la filayaa inay taageeraan soo gudbinta BLA ee suurtagalka ah FDA ee hoos timaada dariiqa oggolaanshaha la dedejiyey ee qaybta hore ee 2024.

Imlifidase waxay hore u heshay oggolaansho suuqgeyn shuruudaysan oo Yurub ah oo loogu talagalay daawaynta miyir-qabka ee bukaannada beeralayda kelyaha ee qaangaarka ah ee aadka u dareenka leh ee leh is-dhaafsi togan oo ka dhan ah deeq-bixiye dhintay.

<

War ku saabsan qoraaga

Linda Hohnholz

Tafatiraha guud ee eTurboNews ku salaysan eTN HQ.

Rukumo
Ogeysii
martida
0 Comments
Jawaabaha Gudaha ah
Eeg dhammaan faallooyinka
0
Waan jeclaan lahaa fikradahaaga, fadlan faallo ka bixi.x
()
x
La wadaag...