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:
- The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date by three months to review additional data submitted by AbbVie, including information about the on-body injector, for this new proposed indication.
- in 2019 to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
- Food and Drug Administration (FDA) has extended its review period for SKYRIZI® (risankizumab-rzaa) for the treatment of moderate to severe Crohn’s disease in patients 16 years and older.
