Kajeno AbbVie o phatlalalitse hore US Food and Drug Administration (FDA) e ekelitse nako ea eona ea tlhahlobo bakeng sa SKYRIZI® (risankizumab-rzaa) bakeng sa kalafo ea lefu la Crohn le itekanetseng ho isa ho le matla ho bakuli ba lilemo tse 16 le ho feta.
FDA e ekelitse letsatsi la ts'ebetso la Prescription Drug User Fee Act (PDUFA) ka likhoeli tse tharo ho lekola lintlha tse ling tse rometsoeng ke AbbVie, ho kenyelletsa le tlhahisoleseling mabapi le ente ea 'mele, bakeng sa pontšo ena e ncha e reriloeng. Matšoao a amohetsoeng hajoale bakeng sa SKYRIZI ha a angoe ke katoloso ena.
SKYRIZI e amohetsoe US ka selemo sa 2019 ho alafa plaque psoriasis e itekanetseng ho isa ho e matla ho batho ba baholo bao e leng baemeli ba systemic therapy kapa phototherapy. Pejana selemong sena, FDA e amohetse SKYRIZI ho phekola ramatiki e sebetsang ea psoriatic ho batho ba baholo.
SKYRIZI ke karolo ea tšebelisano lipakeng tsa Boehringer Ingelheim le AbbVie, 'me AbbVie e etella pele nts'etsopele le khoebo ea SKYRIZI lefatšeng ka bophara.