U-AbbVie namuhla umemezele ukuthi i-US Food and Drug Administration (FDA) yelule isikhathi sayo sokubuyekeza i-SKYRIZI® (risankizumab-rzaa) ukuze zelashwe isifo sika-Crohn esimaphakathi kuya kwesinzima ezigulini ezineminyaka engu-16 nangaphezulu.
I-FDA yelule idethi yesenzo Somthetho Wokusebenzisa Izidakamizwa Ezibhalwe Kadokotela (PDUFA) ngezinyanga ezintathu ukuze ibuyekeze idatha eyengeziwe ethunyelwe ngabakwa-AbbVie, okuhlanganisa ulwazi olumayelana nomjovo osebenza emzimbeni, lwalesi nkomba esisha esihlongozwayo. Izinkomba ezigunyazwe njengamanje ze-SKYRIZI azithintwa lesi sandiso.
I-SKYRIZI yagunyazwa e-US ngo-2019 ukwelapha i-plaque psoriasis emaphakathi kuya kokuqina kubantu abadala abaqokelwe ukwelashwa kwe-systemic noma i-phototherapy. Ngasekuqaleni kwalo nyaka, i-FDA igunyaze i-SKYRIZI ukuthi yelaphe isifo samathambo esisebenzayo se-psoriatic kubantu abadala.
I-SKYRIZI iyingxenye yokubambisana phakathi kwe-Boehringer Ingelheim ne-AbbVie, ne-AbbVie ehamba phambili ekuthuthukisweni nasekuhwebeni kwe-SKYRIZI emhlabeni jikelele.
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- 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.
