I-Amgen namuhla imemezele imiphumela yokuhlaziywa okuhlanganisiwe kwe-post-hoc kweSigaba 3 esibalulekile se-NAVIGATOR kanye ne-PATHWAY Isigaba sesi-2b sokuhlola kubonise i-TEZSPIRE™ (tezepelumab-ekko) ibonise ukwehla kwezinga lonyaka lokunyuka kwesifuba somoya (AAER) kuwo wonke amaqoqo amancane eziguli ezinesifuba somoya esibi kakhulu. 1 Lokhu okutholakele kusekela indima ye-TEZSPIRE njengokwelashwa kwesigaba sokuqala kubantu abaningi abaphila nesifuba somoya esibi kakhulu, kungakhathaliseki amazinga e-biomarker.1
Ekuhlaziyweni okuhlanganisiwe, i-TEZSPIRE, lapho yengezwe ekunakekelweni okujwayelekile (i-SoC), yehlisa ukushuba kwesifuba somoya ezigulini, kungakhathaliseki ukuthi isibalo sokuqala se-eosinophil segazi, ikhombisa ukusebenza kahle okungaguquki nge-71% (≥300 amaseli nge-microliter ngayinye), 48% (<300 amaseli nge-microliter ngayinye) kanye no-48% (<150 amaseli nge-microliter ngayinye) ukunciphisa ku-AAER ngaphezu kwamaviki angu-52, uma kuqhathaniswa ne-placebo engezwe ku-SoC.1 Ekuhlaziyweni okufanayo, i-TEZSPIRE iphinde yabonisa ukuthuthukiswa kwe-AAER ezigulini kungakhathaliseki ukuthi i-nitric oxide ekhishwe yi-fractional ( Izinga le-FeNO) kanye nesimo sokungezwani komzimba ngaphezu kwamaviki angu-52, uma kuqhathaniswa ne-placebo.1
Ukwengeza, ekuhlaziyweni kokuhlola okushiwo kusengaphambili okuvela ku-NAVIGATOR, i-TEZSPIRE ibonise ukusebenza ngendlela efanayo unyaka wonke kungakhathaliseki isizini.2 Idatha ibonisa ukuthi i-TEZSPIRE yehlise i-AAER ngo-63% (ebusika), 46% (entwasahlobo), 62% (ehlobo) kanye I-54% (ekwindla) uma iqhathaniswa ne-placebo.2 Inani leziguli ezinokweqisa laliphansi eqenjini le-TEZSPIRE kuneqembu le-placebo kuzo zonke izinkathi zonyaka.2
“Iningi leziguli ezinesifuba somoya ezinzima zinezisusa eziningi zokuvuvukala, okubangelwa izinto ezingezwani nomzimba, izifo ezibangelwa amagciwane kanye namagciwane, kanye nokungcoliswa komoya, konke okungaba nomthelela ekwandeni okuqhubekayo. Le miphumela emisha iqokomisa amandla e-TEZSPIRE okunciphisa ukushuba okukhulu kwesifuba somoya ezigulini kungakhathalekile amazinga e-biomarker kanye nezimbangela zonyaka,” kusho uDkt. Jonathan Corren, ilungu le-clinical faculty e-David Geffen School of Medicine, UCLA, kanye nomphenyi oyinhloko wesivivinyo se-PATHWAY.
"Sijabule ngokuqhubeka nokubona iziguli zithola ukuhlaselwa kwesifuba somoya okumbalwa kulandela ukwelashwa nge-TEZSPIRE ngokusekelwe emiphumeleni yokuhlaziywa kwakamuva kwe-NAVIGATOR kanye nokuhlolwa kwe-PATHWAY," kusho uDavid M. Reese, MD, iphini likamongameli we-Research and Development e-Amgen. "Le miphumela iqinisa inkolelo yethu yokuthi i-TEZSPIRE inamandla okuba umuthi oguqulayo kubantu abaphila nesifuba somoya esibi kungakhathaliseki ukuthi isizini isiphi noma uhlobo oluthile lwesifuba somoya esibi kakhulu."
Le miphumela yethulwa ku-2022 American Academy of Allergy, Asthma & Immunology (AAAAI) Meeting.
I-TEZSPIRE igunyazwe e-United States yokwelashwa kwesifuba somoya esinamandla futhi ingaphansi kokubuyekezwa okuqondiswayo e-EU, eJapane nakwamanye amazwe amaningana emhlabeni jikelele.
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- Ekuhlaziyeni okuhlanganisiwe, i-TEZSPIRE, lapho yengezwa ekunakekelweni okujwayelekile (i-SoC), yehlisa ukushuba kwesifuba somoya ezigulini, kungakhathaliseki ukuthi isibalo sokuqala se-eosinophil segazi, ikhombisa ukusebenza kahle okungaguquki nge-71% (≥300 amaseli nge-microliter ngayinye), 48% (<300 amaseli nge-microliter ngayinye) kanye nokunciphisa okungu-48% (<150 amaseli nge-microliter ngayinye) ku-AAER kumaviki angu-52, uma kuqhathaniswa ne-placebo engezwe ku-SoC.
- “Le miphumela iqinisa inkolelo yethu yokuthi i-TEZSPIRE inamandla okuba umuthi oguqulayo kubantu abaphila nesifuba somoya esibi kungakhathaliseki ukuthi isizini isiphi noma uhlobo oluthile lwesifuba somoya esibi kakhulu.
- I-TEZSPIRE igunyazwe e-United States yokwelashwa kwesifuba somoya esinamandla futhi ingaphansi kokubuyekezwa okuqondiswayo e-EU, eJapane nakwamanye amazwe amaningana emhlabeni jikelele.
