AbbVie a yau ta sanar da cewa Hukumar Kula da Abinci da Magunguna ta Amurka (FDA) ta tsawaita lokacin bita don SKYRIZI® (risankizumab-rzaa) don magance matsananciyar cutar Crohn a cikin marasa lafiya 16 shekaru da haihuwa.
FDA ta tsawaita Dokar Kuɗin Mai Amfani da Magungunan Magunguna (PDUFA) da kwanan wata uku don sake duba ƙarin bayanan da AbbVie ya gabatar, gami da bayani game da allurar kan-jiki, don wannan sabon nunin da aka gabatar. A halin yanzu da aka amince da alamun SKYRIZI wannan tsawaita bai shafe su ba.
An amince da SKYRIZI a cikin Amurka a cikin 2019 don magance matsakaici zuwa matsananciyar cutar psoriasis a cikin manya waɗanda ke takarar neman tsarin jiyya ko maganin hoto. A farkon wannan shekara, FDA ta amince da SKYRIZI don magance cututtukan cututtuka na psoriatic a cikin manya.
SKYRIZI wani ɓangare ne na haɗin gwiwa tsakanin Boehringer Ingelheim da AbbVie, tare da AbbVie jagorancin ci gaba da kasuwanci na SKYRIZI a duniya.