AbbVie lero adalengeza kuti bungwe la US Food and Drug Administration (FDA) lawonjezera nthawi yake yowunikira SKYRIZI® (risankizumab-rzaa) kuti athe kuchiza matenda a Crohn apakati kapena ovuta kwa odwala azaka 16 kapena kuposerapo.
A FDA awonjezera tsiku la Prescription Drug User Fee Act (PDUFA) ndi miyezi itatu kuti awonenso zina zomwe zatumizidwa ndi AbbVie, kuphatikiza chidziwitso chokhudza jakisoni wapathupi, pachiwonetsero chatsopanochi. Zowonetsa pano zovomerezeka za SKYRIZI sizikhudzidwa ndi kukulitsa uku.
SKYRIZI idavomerezedwa ku US mchaka cha 2019 kuchiza psoriasis yapakatikati mpaka yowopsa mwa akulu omwe akufuna kulandira chithandizo chamankhwala kapena Phototherapy. Kumayambiriro kwa chaka chino, a FDA adavomereza SKYRIZI kuchiza nyamakazi yogwira ya psoriatic mwa akulu.
SKYRIZI ndi gawo la mgwirizano pakati pa Boehringer Ingelheim ndi AbbVie, AbbVie akutsogolera chitukuko ndi malonda a SKYRIZI padziko lonse lapansi.
ZOMWE MUNGACHITE PA NKHANIYI:
- A FDA awonjezera tsiku la Prescription Drug User Fee Act (PDUFA) ndi miyezi itatu kuti awonenso zina zomwe zatumizidwa ndi AbbVie, kuphatikiza chidziwitso chokhudza jakisoni wapathupi, pachiwonetsero chatsopanochi.
- mu 2019 kuchiza psoriasis wapakatikati mpaka wowopsa mwa akulu omwe akufuna kulandira chithandizo chamankhwala kapena phototherapy.
- Food and Drug Administration (FDA) yawonjezera nthawi yake yowunikira SKYRIZI® (risankizumab-rzaa) kuti athe kuchiza matenda a Crohn omwe ali ndi zaka 16 kapena kuposerapo.
