Isicelo esisha somuthi wokwelapha i-anemia ngenxa yesifo sezinso esingamahlalakhona

I-Akebia Therapeutics®, Inc. namuhla imemezele ukuthi i-US Food and Drug Administration (FDA) ikhiphe incwadi yempendulo ephelele (CRL) ku-Akebia's New Drug Application (NDA) ye-vadadustat, i-oral hypoxia-inducible factor prolyl hydroxylase (HIF- PH) inhibitor ngaphansi kokubuyekezwa kokwelashwa kwe-anemia ngenxa yesifo sezinso esingamahlalakhona (CKD). I-FDA ikhipha i-CRL ukuze ibonise ukuthi umjikelezo wokubuyekeza wesicelo uphelele nokuthi isicelo asikakalungeli ukugunyazwa ngendlela esikuyo manje.

I-FDA iphethe ngokuthi idatha ku-NDA ayikusekeli ukuhlolwa kwengozi yenzuzo evumayo ye-vadadustat ye-dialysis kanye neziguli ezingezona i-dialysis. I-FDA izwakalise ukukhathazeka ngokuphepha iphawula ukwehluleka ukuhlangabezana nokungabi ngaphansi kwe-MACE kubantu abangewona i-dialysis, ubungozi obukhulayo bezehlakalo ze-thromboembolic, obuqhutshwa i-vascular access thrombosis ezigulini ze-dialysis, kanye nengozi yokulimala kwesibindi okubangelwa izidakamizwa. I-CRL yathi i-Akebia ingahlola izindlela zokukhombisa ukuhlolwa kwengozi yenzuzo okuhle ngokusebenzisa izivivinyo ezintsha zomtholampilo. I-Akebia izoxoxa ngemininingwane ye-CRL nabalingani bayo bokusebenzisana futhi icele umhlangano ne-FDA.

“Sidumele kakhulu ngokuthola i-CRL ye-vadadustat, ukwelapha okunamandla okusiza iziguli ezine-anemia ngenxa ye-CKD. Siyaqhubeka nokukholelwa ukuthi idatha isekela ukuhlolwa okuhle kwengozi ye-vadadustat ezigulini ezine-anemia ngenxa ye-CKD, ikakhulukazi ezigulini ze-dialysis, "kusho u-John P. Butler, Isikhulu Esiphezulu se-Akebia. “Naphezu kwalesi siphazamiso, siyaqhubeka nokusebenzela inhloso yethu yokwenza ngcono izimpilo zabantu abathintwe yisifo sezinso.”

Ngo-Okthoba 2021, uzakwethu wokubambisana ka-Akebia, i-Otsuka Pharmaceutical Co., Ltd. (Otsuka), wathumela isicelo sokuqala sokugunyazwa ukumaketha (i-MAA) se-vadadustat ku-European Medicines Agency ye-vadadustat, yokwelapha i-anemia ngenxa ye-CKD kubantu abadala; ukubuyekezwa kuyaqhubeka. E-Japan, i-vadadustat ivunyelwe njengokwelashwa kwe-anemia ngenxa ye-CKD kuzo zombili iziguli ezincike ku-dialysis nezingezona i-dialysis.

I-Akebia izobamba ucingo lwengqungquthela ngoLwesithathu, Mashi 30 ngo-6:00 pm Isikhathi SaseMpumalanga ukuze kuxoxwe nge-CRL nezinyathelo ezilandelayo.