Sabuwar aikace-aikacen magani don maganin anemia saboda ciwon koda na yau da kullun

A KYAUTA Kyauta 8 | eTurboNews | eTN
Avatar na Linda Hohnholz
Written by Linda Hohnholz

Akebia Therapeutics®, Inc.. PH) mai hanawa a ƙarƙashin bita don maganin anemia saboda cututtukan koda na yau da kullun (CKD). FDA ta ba da CRL don nuna cewa sake duba aikace-aikacen ya cika kuma cewa aikace-aikacen bai shirya don amincewa ba a cikin sigar yanzu.

FDA ta kammala cewa bayanan da ke cikin NDA ba sa goyan bayan ingantaccen fa'ida-hadarin kima na vadadustat don dialysis da marasa lafiya marasa lafiya. FDA ta bayyana damuwa game da rashin lafiyar da ke lura da gazawar saduwa da rashin ƙarfi a cikin MACE a cikin yawan marasa lafiya marasa lafiya, yawan haɗarin abubuwan da ke faruwa na thromboembolic, wanda ke haifar da thrombosis na jijiyoyi a cikin marasa lafiya na dialysis, da kuma hadarin hanta da miyagun ƙwayoyi ya haifar. CRL ta bayyana cewa Akebia na iya gano hanyoyin da za a iya nuna ingantaccen ƙimar haɗarin fa'ida ta sabbin gwaje-gwajen asibiti. Akebia zai tattauna cikakkun bayanai game da CRL tare da abokan haɗin gwiwarsa kuma ya nemi ganawa da FDA.

"Mun yi matukar takaicin samun CRL don vadadustat, magani wanda ke da yuwuwar taimakawa marasa lafiya da anemia saboda CKD. Muna ci gaba da yin imani da bayanan suna goyan bayan ingantaccen ƙimar fa'ida-hadarin vadadustat ga marasa lafiya da anemia saboda CKD, musamman a cikin marasa lafiya na dialysis, "in ji John P. Butler, Babban Jami'in Akebia. "Duk da wannan koma baya, muna ci gaba da yin aiki ga manufarmu don inganta rayuwar mutanen da cutar koda ta shafa."

A cikin Oktoba 2021, abokin haɗin gwiwar Akebia, Otsuka Pharmaceutical Co., Ltd. (Otsuka), ya ƙaddamar da aikace-aikacen ba da izini na tallace-tallace na farko (MAA) don vadadustat ga Hukumar Kula da Magunguna ta Turai don vadadustat, don maganin anemia saboda CKD a cikin manya; bita yana gudana. A Japan, an amince da vadadustat azaman maganin anemia saboda CKD a cikin duka masu dogaro da dialysis da marasa lafiya waɗanda ba su da dialysis.

Akebia za ta karbi bakuncin kiran taron Laraba, 30 ga Maris da karfe 6:00 na yamma agogon Gabas don tattaunawa kan CRL da matakai na gaba.

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Avatar na Linda Hohnholz

Linda Hohnholz

Edita a shugaba don eTurboNews bisa ga eTN HQ.

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