Akebia Therapeutics®, Inc. nhasi yazivisa kuti US Food and Drug Administration (FDA) yaburitsa tsamba yemhinduro yakakwana (CRL) kuAkebia's New Drug Application (NDA) yevadadustat, yekuferefeta oral hypoxia-inducible factor prolyl hydroxylase (HIF- PH) inhibitor iri kuongororwa kurapwa kweanemia nekuda kwechirwere cheitsvo chisingaperi (CKD). Iyo FDA inoburitsa CRL kuratidza kuti kutenderera kwechikumbiro kwapera uye kuti kunyorera hakuna kugadzirira kubvumidzwa mune yazvino fomu.
Iyo FDA yakagumisa kuti iyo data muNDA haitsigire yakanakira bhenefiti-njodzi ongororo yevadadustat ye dialysis uye vasiri dialysis varwere. Iyo FDA yakaratidza kushushikana kwekuchengetedza ichiona kutadza kusangana nekusiri pasi-pasi muMACE muhuwandu hwevarwere vasiri dialysis, njodzi yakawedzera yezviitiko zvethromboembolic, inotungamirwa nevascular access thrombosis muvarwere vedialysis, uye njodzi yekukuvara kwechiropa kunokonzerwa nezvinodhaka. Iyo CRL yakataura kuti Akebia inogona kutsvaga nzira dzekugona kuratidza yakanakira bhenefiti-njodzi kuongororwa kuburikidza nemiedzo mitsva yekiriniki. Akebia ichakurukura nezve CRL nevabatsiri vayo uye vokumbira musangano neFDA.
“Takarwadziwa zvikuru kuwana CRL yevadadustat, mushonga unokwanisa kubatsira varwere vane anemia nekuda kweCKD. Tinoramba tichitenda kuti data inotsigira kuongororwa kwengozi yevadadustat kune varwere vane anemia nekuda kweCKD, kunyanya muvarwere vedialysis, "akadaro John P. Butler, Chief Executive Officer weAkebia. "Zvisinei nekukanganisa uku, tinoramba tichishanda takatarisana nechinangwa chedu chekuvandudza hupenyu hwevanhu vakabatwa nechirwere cheitsvo."
Muna Gumiguru 2021, mubatsiri waAkebia, Otsuka Pharmaceutical Co., Ltd. (Otsuka), akatumira chikumbiro chekutanga chemvumo yekushambadzira (MAA) yevadadustat kuEuropean Medicines Agency yevadadustat, kurapwa kweanemia nekuda kweCKD muvakuru; kuongorora kuri kuenderera mberi. KuJapan, vadadustat inotenderwa semushonga weanemia nekuda kweCKD mune vese vanotsamira nedialysis-vasina dialysis vanotsamira varwere vakuru.
Akebia ichaita musangano wekufona neChitatu, Kurume 30 na6:00 pm Nguva dzekumabvazuva kukurukura nezveCRL uye matanho anotevera.
ZVOKUBVA MUNYAYA INO:
- Iyo FDA inoburitsa CRL kuratidza kuti kutenderera kwechikumbiro kwapera uye kuti kunyorera hakuna kugadzirira kubvumidzwa mune yazvino fomu.
- Iyo FDA yakaratidza kushushikana kwekuchengetedza ichiona kutadza kusangana nekusava pasi-pasi muMACE muhuwandu hwevarwere vasina dialysis, njodzi yakawedzera yezviitiko zvethromboembolic, inotungamirwa nevascular access thrombosis muvarwere vedialysis, uye njodzi yekukuvara kwechiropa kunokonzerwa nezvinodhaka.
- Iyo FDA yakagumisa kuti iyo data muNDA haitsigire yakanakira bhenefiti-njodzi ongororo yevadadustat ye dialysis uye vasiri dialysis varwere.
