Ua hoʻolaha ʻo Regeneron Pharmaceuticals, Inc. a me Sanofi i kēia lā ua hoʻonui ka European Commission (EC) i ka mana kūʻai aku no Dupixent® (dupilumab) ma ka European Union. Ua ʻae ʻia ʻo Dupixent i nā keiki i piha i ka makahiki 6 a hiki i ka 11 makahiki ma ke ʻano he lāʻau mālama mālama hou no ka hānō koʻikoʻi me ka ʻano ʻano 2 ʻona i hōʻike ʻia e nā eosinophils koko kiʻekiʻe a / a i ʻole hāpai ʻia ka fractional exhaled nitric oxide (FeNO), ka poʻe i mālama ʻole ʻia me ka medium a kiʻekiʻe inhaled corticosteroids (ICS) a me kekahi lāʻau lapaʻau no ka mālama ʻana.
"ʻO ka'āpono o kēia lā maʻEulopa eʻike i nā pono o Dupixent i ke kōkuaʻana i nā keiki e noho nei me nā hopena hohonu o ka hānō nui, e like me nā hōʻeha hānō hikiʻole ke manaʻoʻia, ka hoʻohaunaele maʻamau i nā hana o kēlā me kēia lā a me ka hoʻohanaʻana i nā steroids pūnaewele e hiki ke pale i ka uluʻana o nā keiki," wahi a George D. Yancopoulos. , MD, Ph.D., Pelekikena a Luna Nui ʻepekema ma Regeneron. "ʻO Dupixent wale nō ka lāʻau lapaʻau e hoʻopaʻa pono ai i ʻelua mau mea hoʻokele nui o ke ʻano 2 ʻaʻa, IL-4 a me IL-13, ka mea i hōʻike ʻia e kā mākou mau hoʻāʻo he hana nui i ka hānō kamaliʻi, a me nā kūlana pili e like me ka rhinosinusitis maʻi me ka ihu. polyposis a me ka maʻi co-morbid pinepine, ka dermatitis atopic. I loko o nā hoʻokolohua lapaʻau, ua hoʻemi nui ʻo Dupixent i nā hōʻeha hānō, kōkua i nā keiki e hanu maikaʻi a hoʻomaikaʻi i ko lākou olakino pili i ke ola. Ke hoʻomau nei mākou i ka noiʻi ʻana iā Dupixent i nā kūlana ʻē aʻe kahi e hoʻopilikia nui ai ka maʻi ʻano 2 i ke ola o nā mea maʻi, me ka eosinophilic esophagitis, prurigo nodularis a me ka urticaria spontaneous.
ʻO ka hānō kekahi o nā maʻi maʻamau maʻamau i nā keiki. Hiki i ka 85% o nā keiki me ka hānō ke loaʻa i ke ʻano 2 ʻona a ʻoi aku ka nui o ke kaumaha o ka maʻi. ʻOiai ka mālama ʻana me ka ICS mālama maʻamau a me nā bronchodilators o kēia manawa, hiki i kēia mau keiki ke hoʻomau i ka ʻike ʻana i nā hōʻailona koʻikoʻi e like me ka ʻuʻu ʻana, ka uila a me ka pilikia o ka hanu ʻana. Hiki i ka hānō koʻikoʻi ke hoʻopilikia i ka ulu ʻana o nā ala ea o nā keiki a hiki ke hoʻoweliweli i ke ola. Hiki i nā keiki me ka hānō koʻikoʻi ke koi aku i ka hoʻohana ʻana i nā papa he nui o nā corticosteroids systemic e lawe ana i nā pilikia nui. Hiki ke hoʻopilikia i nā hana o kēlā me kēia lā, e like me ka hiamoe ʻana, ke hele ʻana i ke kula a me ka pāʻani ʻana i nā haʻuki.
ʻO Dupixent, ka mea i hana ʻia me ka ʻenehana VelocImmune® proprietary o Regeneron, he antibody monoclonal piha kanaka e pale ana i ka hōʻailona o nā ala interleukin-4 (IL-4) a me interleukin-13 (IL-13) a ʻaʻole ia he immunosuppressant. Ma ka hōʻike ʻana i ka pōmaikaʻi koʻikoʻi koʻikoʻi me ka emi ʻana o ka mumū ʻano 2 ma hope o IL-4 a me IL-13 blockade me Dupixent, ua hoʻokumu ka papahana ʻo Dupixent Phase 3 ʻo IL-4 a me IL-13 nā mea hoʻokele koʻikoʻi o ke ʻano 2 ʻaʻa. He kuleana koʻikoʻi ia i nā maʻi like ʻole a pili pinepine i ka Dupixent i ʻae ʻia e like me ka hānō, ka dermatitis atopic a me ka rhinosinusitis maʻi me ka polyposis ihu (CRSwNP), a me nā maʻi noiʻi e like me eosinophilic esophagitis a me prurigo nodularis, i aʻo ʻia. i nā hoʻokolohua Phase 3.
"ʻOliʻoli mākou i ka lawe ʻana i ka ʻike palekana a me ka maikaʻi o Dupixent i nā poʻe maʻi ʻōpio e noho ana me ka hānō koʻikoʻi ʻole ma ʻEulopa. Ma waho aʻe o ka hōʻemi nui ʻana i nā hōʻeha hānō koʻikoʻi a me ka hoʻomaikaʻi ʻana i ka hana o ka māmā, ua hōʻemi pū nā poʻe maʻi i kā mākou hoʻokolohua lapaʻau i kā lākou hoʻohana corticosteroid waha. He mea koʻikoʻi kēia no ka mea he mau lāʻau kēia e hiki ke lawe i nā pilikia palekana nui inā hoʻohana lōʻihi, "wahi a Naimish Patel, MD Head of Global Development, Immunology and Inflammation ma Sanofi. "Ke hōʻike nei kēia ʻae i kā mākou hoʻomau mau ʻana i ka lawe ʻana iā Dupixent i nā mea maʻi e like me ka hiki ke loaʻa i nā hopena maikaʻi ʻole o ka hānō nui me ka manaʻolana e hoʻomaikaʻi i ko lākou ola."
Hoʻokumu ʻia ka hoʻoholo EC ma luna o ka ʻikepili koʻikoʻi mai ka Phase 3 VOYAGE hoʻāʻo e loiloi ana i ka pono a me ka palekana o Dupixent i hui pū ʻia me ka maʻi hānō maʻamau i nā keiki 408 me ka hānō haʻahaʻa a paʻakikī ʻole.
Ua loiloi ʻia ʻelua mau heluna kanaka i hōʻike mua ʻia me nā hōʻike o ke ʻano ʻano ʻano 2 no ka nānā mua ʻana: 1) nā maʻi me ka baseline blood eosinophils (EOS) ≥300 cell/μl (n=259) a me 2) nā mea maʻi me ka baseline FeNO ≥20 ʻāpana i kēlā me kēia. biliona (ppb) a i ʻole ke koko kumu EOS ≥150 cell/μl (n=350). ʻO nā maʻi i hoʻohui iā Dupixent i ka mālama maʻamau i kēia mau pūʻulu ʻelua, ua ʻike lākou:
• Ua ho'emi nui 'ia ka nui o ka ma'i hānō ko'iko'i, me ka 65% a me 59% awelika ho'ēmi ma luna o ho'okahi makahiki i ho'ohālikelike 'ia me ka placebo (0.24 a me 0.31 hanana i kēlā me kēia makahiki no Dupixent vs. 0.67 a me 0.75 no ka placebo).
• ʻIke ʻia ka hana ʻana o ka māmā ma mua o ʻelua pule a mālama ʻia a hiki i 52 pule, ana ʻia e ka pākēneka i wānana ʻia FEV1 (FEV1pp).
• Ma nā pule he 12, ua hoʻomaikaʻi ka poʻe maʻi e lawe ana i ka Dupixent i kā lākou māmā ma o 5.32 a me 5.21 mau helu pākēneka i hoʻohālikelike ʻia me kahi placebo.
• Hoʻonui i ka mana hānō, me 81% a me 79% o nā maʻi e hōʻike ana i kahi hoʻomaikaʻi koʻikoʻi o ka maʻi ma nā wiki 24, e pili ana i nā hōʻailona maʻi a me ka hopena i hoʻohālikelike ʻia me 64% a me 69% o nā maʻi placebo.
• Hoʻonui i ka maikaʻi o ke ola e pili ana i ke olakino, me 73% a me 73% o nā maʻi e hōʻike ana i kahi hoʻomaikaʻi koʻikoʻi o ka maʻi ma 24 pule, i hoʻohālikelike ʻia me 63% a me 65% o nā maʻi placebo.
• Hoʻemi ʻia ka hoʻohana ʻana i ka corticosteroid systemic ma ka awelika o 66% a me 59% ma mua o hoʻokahi makahiki i hoʻohālikelike ʻia me kahi placebo (0.27 a me 0.35 mau papa i kēlā me kēia makahiki no Dupixent vs. 0.81 a me 0.86 no kahi placebo, kēlā me kēia).
Ua kūlike nā hopena palekana mai ka ho'āʻo ʻana me ka ʻike palekana ʻike ʻia o Dupixent i nā maʻi o 12 makahiki a ʻoi aʻe me ka maʻi hānō haʻahaʻa a koʻikoʻi. ʻO ka nui o nā hanana ʻino he 83% no Dupixent a me 80% no kahi placebo. ʻO nā hanana ʻino i ʻike pinepine ʻia me Dupixent i hoʻohālikelike ʻia me ka placebo, ʻo ia ka hopena o ka wahi injection (18% Dupixent, 13% placebo), nā maʻi maʻi o ka respiratory respiratory tract (12% Dupixent, 10% placebo) a me eosinophilia (7% Dupixent, 1% placebo. ). Ua ʻike pinepine ʻia nā maʻi Helminth me Dupixent i nā mea maʻi mai 6 a 11 mau makahiki a ua hōʻike ʻia ma 2% o nā maʻi Dupixent a me 0% o nā maʻi placebo.
He aha e lawe ʻia mai kēia ʻatikala:
- By demonstrating significant clinical benefit together with a decrease in type 2 inflammation following IL-4 and IL-13 blockade with Dupixent, the Dupixent Phase 3 clinical program has established that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases for which Dupixent is approved including asthma, atopic dermatitis and chronic rhinosinusitis with nasal polyposis (CRSwNP), as well as investigational diseases such as eosinophilic esophagitis and prurigo nodularis, which have been studied in Phase 3 trials.
- “Dupixent is the only treatment available that specifically blocks two key drivers of type 2 inflammation, IL-4 and IL-13, which our trials show plays a major role in childhood asthma, as well as in related conditions such as chronic rhinosinusitis with nasal polyposis and the often co-morbid condition, atopic dermatitis.
- “Today’s approval in Europe recognizes the benefits of Dupixent in helping children living with the profound effects of severe asthma, including unpredictable asthma attacks, routine disruption to daily activities and the use of systemic steroids that can impede children’s growth,”.
