I-Dupixent Igunyazwe Izingane Ezinesifuba Esinamandla

A BAMBA MahhalaRelease 1 | eTurboNews | eTN
Isithombe sikaLinda Hohnholz
Ibhalwe ngu Linda Hohnholz

I-Regeneron Pharmaceuticals, Inc. kanye ne-Sanofi namuhla bamemezele ukuthi I-European Commission (EC) yandise ukugunyazwa kokumaketha kwe-Dupixent® (dupilumab) e-European Union. I-Dupixent manje isigunyazwe nasezinganeni ezineminyaka engu-6 kuye kweyi-11 njengokwelashwa okungeziwe kwesondlo sesifuba somoya esinamandla nokuvuvukala kohlobo 2 olubonakala ngama-eosinophil egazi aphakanyisiwe kanye/noma ama-fractional exhaled nitric oxide (FeNO) akhushuliwe (FeNO), angalawulwa ngendlela efanele nge-medium to. umthamo omkhulu we-corticosteroids (ICS) ehogelwe kanye nomunye umkhiqizo womuthi wokwelashwa kokulungisa.

“Ukugunyazwa namuhla eYurophu kuyaziqaphela izinzuzo ze-Dupixent ekusizeni izingane eziphila nemiphumela ejulile yesifuba somoya esinamandla, kuhlanganise nokuhlasela kwesifuba somoya okungalindelekile, ukuphazamiseka okuvamile emisebenzini yansuku zonke kanye nokusetshenziswa kwe-systemic steroids engakhinyabeza ukukhula kwezingane,” kusho uGeorge D. Yancopoulos. , MD, Ph.D., uMongameli kanye Nesikhulu Esiyinhloko Sezesayensi e-Regeneron. "I-Dupixent ukuphela kwendlela yokwelapha etholakalayo evimba ngokuqondile abashayeli ababili ababalulekile bokuvuvukala kohlobo 2, i-IL-4 ne-IL-13, ukuhlolwa kwethu kubonisa indima enkulu ku-asthma yezingane, kanye nasezimeni ezihlobene ezifana ne-rhinosinusitis engapheli ene-nasal. i-polyposis kanye nesimo esivame ukuhambisana, i-atopic dermatitis. Ezivivinyweni zomtholampilo, i-Dupixent yehlisa kakhulu ukuhlaselwa yisifuba somoya, yasiza izingane ukuba ziphefumule kangcono futhi yathuthukisa izinga lempilo yazo ehlobene nempilo. Siphinde sizibophezele ekuphenyeni i-Dupixent kwezinye izimo lapho ukuvuvukala kohlobo 2 kungase kube nomthelela omkhulu ezimpilweni zeziguli, okuhlanganisa i-eosinophilic esophagitis, i-prurigo nodularis kanye ne-urticaria ezenzakalelayo engapheli.

Isifuba somoya singesinye sezifo ezingelapheki ezivame kakhulu ezinganeni. Izingane ezifika ku-85% ezinesifuba somoya zingase zibe nokuvuvukala kohlobo 2 futhi maningi amathuba okuba zibe nomthwalo ophakeme wezifo. Naphezu kokwelashwa nge-ICS yokunakekelwa okujwayelekile kanye nama-bronchodilator, lezi zingane zingase ziqhubeke zithola izimpawu ezingathi sína njengokukhwehlela, ukuhefuzela kanye nobunzima bokuphefumula. Isifuba somoya esinamandla singase sibe nomthelela endleleni yokuphefumula yezingane futhi sibangele ukwanda okungase kube yingozi empilweni. Izingane ezinesifuba somoya okunzima nazo zingase zidinge ukusetshenziswa kwezifundo eziningi ze-systemic corticosteroids ezithwala izingozi ezinkulu. Isifuba somoya esingalawuleki esingalawuleki singaphazamisa imisebenzi yansuku zonke, njengokulala, ukuya esikoleni nokudlala imidlalo.

I-Dupixent, eyasungulwa kusetshenziswa ubuchwepheshe be-Regeneron's VelocImmune®, iyi-antibody ye-monoclonal yomuntu ngokugcwele evimbela ukusayinda kwemikhondo ye-interleukin-4 (IL-4) kanye ne-interleukin-13 (IL-13) futhi ayisona i-immunosuppressive. Ngokubonisa inzuzo ebalulekile yomtholampilo kanye nokuncipha kokuvuvukala kohlobo 2 okulandela ukuvinjwa kwe-IL-4 ne-IL-13 nge-Dupixent, uhlelo lwe-Dupixent Phase 3 lomtholampilo luthole ukuthi i-IL-4 ne-IL-13 yizici ezibalulekile zohlobo 2 lokuvuvukala okukhona. idlala indima enkulu ezifweni ezihlobene eziningi nezivame ukuhambisana nokugunyazwa i-Dupixent okuhlanganisa isifuba somoya, i-atopic dermatitis kanye ne-rhinosinusitis engapheli ene-nasal polyposis (CRSwNP), kanye nezifo zophenyo ezifana ne-eosinophilic esophagitis kanye ne-prurigo nodularis, eziye zacwaningwa. ezivivinyweni zeSigaba 3.

“Sijabule ukuletha iphrofayili eqinisekisiwe yokuphepha nokusebenza kahle kwe-Dupixent ezigulini ezisencane eziphila nesifuba somoya esingalawuleki esingalawuleki eYurophu. Ngaphezu kokunciphisa kakhulu ukuhlasela kwesifuba somoya okunzima kanye nokwenza ngcono ukusebenza kwamaphaphu, iziguli ezivivinyweni zethu zomtholampilo nazo zanciphisa ukusebenzisa kwazo i-corticosteroid yomlomo. Lokhu kunengqondo ikakhulukazi njengoba lena kuyimithi engathwala ubungozi obukhulu bokuphepha uma isetshenziswa isikhathi eside,” kusho uNaimish Patel, MD oyiNhloko yeGlobal Development, Immunology and Inflammation kwaSanofi. "Lokhu kugunyazwa kugcizelela ukuzibophezela kwethu okuqhubekayo ekuletheni i-Dupixent ezigulini eziningi ezihlushwa imiphumela emibi yesifuba somoya esinamandla ngethemba lokuthuthukisa izinga lempilo yazo." 

Isinqumo se-EC sisekelwe kudatha ebalulekile evela ocwaningweni lweSigaba 3 VOYAGE oluhlola ukusebenza kahle nokuphepha kwe-Dupixent kuhlanganiswe nokwelashwa kwesifuba somoya okujwayelekile ezinganeni ezingu-408 ezinesifuba somoya esingalawuleki esimaphakathi kuya esibi.

Izibalo ezimbili ezishiwo ngaphambili ezinobufakazi bokuvuvukala kohlobo lwe-2 zahlolwa ukuze kuhlaziywe okuyinhloko: iziguli ze-1) ezine-eosinophils yegazi eyisisekelo (EOS) ≥300 amangqamuzana / μl (n=259) kanye ne-2) iziguli ezine-FeNO eyisisekelo ≥20 izingxenye ngayinye ibhiliyoni (ppb) noma igazi lesisekelo i-EOS ≥150 amaseli/μl (n=350). Iziguli ezengeze i-Dupixent ekunakekelweni okujwayelekile kulawa maqembu amabili, ngokulandelana, zibe nakho:

• Amazinga anciphe kakhulu okuhlaselwa yisifuba somoya okunzima, ngokuncipha kwesilinganiso okungu-65% no-59% ngonyaka owodwa uma kuqhathaniswa ne-placebo (imicimbi engu-0.24 kanye ne-0.31 ngonyaka nge-Dupixent vs. 0.67 kanye no-0.75 ye-placebo, ngokulandelanayo).

• Ukusebenza kwamaphaphu okuthuthukisiwe kubonwe ngokushesha emasontweni amabili futhi kuqhubeka amasonto angama-52, kukalwa ngamaphesenti abikezelwe i-FEV1 (FEV1pp).

• Emavikini angu-12, iziguli ezithatha i-Dupixent zathuthukisa ukusebenza kwamaphaphu azo ngamaphuzu angu-5.32 namaphesenti angu-5.21 uma kuqhathaniswa ne-placebo, ngokulandelanayo.

• Ukulawulwa kwesifuba somoya okuthuthukisiwe, ngama-81% kanye nama-79% eziguli ezibika ukuthuthuka okunenjongo emtholampilo emavikini angama-24, ngokusekelwe ezimpawini zesifo nomthelela uma kuqhathaniswa nama-64% kanye nama-69% eziguli ze-placebo, ngokulandelana.

• Izinga lempilo elihlobene nezempilo elithuthukisiwe, ngama-73% kanye nama-73% eziguli ezibika ukuthuthuka okunenjongo emtholampilo emasontweni angama-24, uma kuqhathaniswa nama-63% nama-65% eziguli ze-placebo, ngokulandelana.

• Ukwehliswa kokusetshenziswa kwe-systemic corticosteroid ngesilinganiso esingu-66% no-59% ngonyaka owodwa uma kuqhathaniswa ne-placebo (izifundo ezingu-0.27 nezingu-0.35 ngonyaka ze-Dupixent vs. 0.81 kanye no-0.86 ze-placebo, ngokulandelanayo).

Imiphumela yokuphepha yocwaningo yayivame ukuhambisana nephrofayili yokuphepha eyaziwayo ye-Dupixent ezigulini ezineminyaka engu-12 nangaphezulu ezinesifuba somoya esingalawuleki esimaphakathi kuya kobukhulu. Izilinganiso eziphelele zezehlakalo ezimbi bekungama-83% e-Dupixent kanye nama-80% e-placebo. Izehlakalo ezimbi ezivame ukubonwa nge-Dupixent uma kuqhathaniswa ne-placebo zihlanganisa ukusabela kwendawo yomjovo (18% Dupixent, 13% placebo), izifo zegciwane lesandulela ngculazi eliphezulu (12% Dupixent, 10% placebo) kanye ne-eosinophilia (7% Dupixent, 1% placebo). ). Ukutheleleka kwe-Helminth nakho kwakuvame ukubonwa nge-Dupixent ezigulini ezineminyaka engu-6 kuye kweyi-11 futhi kwabikwa ku-2% weziguli ze-Dupixent kanye no-0% weziguli ze-placebo.

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Isithombe sikaLinda Hohnholz

Linda Hohnholz

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