AbbVie nhasi yakazivisa kuti US Food and Drug Administration (FDA) yakawedzera nguva yayo yekudzokorora yeSKYRIZI® (risankizumab-rzaa) yekurapa kwepakati kusvika kune yakanyanya chirwere cheCrohn muvarwere vane makore gumi nematanhatu zvichikwira.
Iyo FDA yakawedzera iyo Prescription Drug User Fee Act (PDUFA) zuva rekuita nemwedzi mitatu kuti iongorore imwe dhata yakaunzwa neAbbVie, kusanganisira ruzivo nezve injector ye-pamuviri, yechiratidzo chitsva ichi. Parizvino zviratidzo zvakatenderwa zveSKYRIZI hazvina kukanganiswa nekuwedzera uku.
SKYRIZI yakatenderwa muUS muna 2019 kurapa zvine mwero kusvika kune yakanyanya plaque psoriasis muvakuru vari kukwikwidza systemic therapy kana phototherapy. Pakutanga gore rino, iyo FDA yakabvumidza SKYRIZI kurapa inoshanda psoriatic arthritis muvakuru.
SKYRIZI chikamu chemubatanidzwa pakati peBoehringer Ingelheim neAbbVie, ine AbbVie inotungamira kusimudzira uye kushambadzira kweSKYRIZI pasi rose.
ZVOKUBVA MUNYAYA INO:
- 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.