Isicelo esitsha samachiza kunyango lwe-anemia ngenxa yesifo sezintso ezingapheliyo

I-Akebia Therapeutics®, Inc. namhlanje ibhengeze ukuba i-US Food and Drug Administration (FDA) ikhuphe ileta yempendulo epheleleyo (CRL) kwi-Akebia's New Drug Application (NDA) ye-vadadustat, uphando lwe-oral hypoxia-inducible factor prolyl hydroxylase (HIF- PH) inhibitor phantsi kohlaziyo lonyango lwe-anemia ngenxa yesifo sezintso ezingapheliyo (CKD). I-FDA ikhupha i-CRL ukubonisa ukuba umjikelo wokuphononongwa kwesicelo ugqityiwe kwaye isicelo asikakulungeli ukuvunywa kwifom yangoku.

I-FDA yagqiba ukuba idatha kwi-NDA ayixhasi uvavanyo olufanelekileyo lwengozi ye-vadadustat ye-dialysis kunye nezigulane ezingezizo ze-dialysis. I-FDA ibonise iinkxalabo zokhuseleko eziqaphela ukungaphumeleli ukuhlangabezana nokungabikho ngaphantsi kwe-MACE kwi-non-dialysis yabantu abagulayo, ukwanda komngcipheko weziganeko ze-thromboembolic, eziqhutywa yi-vascular access thrombosis kwizigulane ze-dialysis, kunye nomngcipheko wokulimala kwesibindi esibangelwa ngamachiza. I-CRL yatsho ukuba i-Akebia inokuphonononga iindlela zokubonisa uvavanyo olululo lwenzuzo yomngcipheko ngolingo olutsha lweklinikhi. I-Akebia iya kuxubusha iinkcukacha ze-CRL kunye namaqabane ayo okubambisana kunye nokucela intlanganiso kunye ne-FDA.

“Siphoxeke kakhulu kukufumana iCRL yevadadustat, unyango olunamandla okunceda abaguli abaneanemia ngenxa yeCKD. Siyaqhubeka sikholelwa ukuba idatha ixhasa uvavanyo oluhle lwengozi ye-vadadustat kwizigulane ezine-anemia ngenxa ye-CKD, ngokukodwa kwizigulane ze-dialysis, "kusho uJohn P. Butler, iGosa eliyiNtloko le-Akebia. "Ngaphandle kwesi sithintelo, sisaqhubeka sisebenzela injongo yethu yokuphucula ubomi babantu abachatshazelwa sisifo sezintso."

Ngo-Oktobha 2021, iqabane lokubambisana lika-Akebia, i-Otsuka Pharmaceutical Co., Ltd. (Otsuka), lingenise isicelo sokuqala sogunyaziso lokuthengisa (i-MAA) ye-vadadustat kwi-Arhente yeMithi yaseYurophu ye-vadadustat, yonyango lwe-anemia ngenxa ye-CKD kubantu abadala; uphononongo luyaqhubeka. EJapan, i-vadadustat ivunyiwe njengonyango lwe-anemia ngenxa ye-CKD kuzo zombini izigulane ezixhomekeke kwi-dialysis kunye ne-non-dialysis yabantu abadala.

I-Akebia iya kubamba ucingo lwenkomfa ngoLwesithathu, ngo-Matshi 30 kwi-6: 00 pm Ixesha laseMpuma ukuxoxa nge-CRL kunye namanyathelo alandelayo.