Regeneron Pharmaceuticals, Inc. le Sanofi kajeno ba phatlalalitse hore Komisi ea Europe (EC) e ekelitse tumello ea ho rekisa bakeng sa Dupixent® (dupilumab) European Union. Dupixent e se e boetse e amohetsoe ho bana ba lilemo tse 6 ho isa ho tse 11 joalo ka kalafo ea tlatsetso bakeng sa asthma e matla e nang le ho ruruha ha mofuta oa 2 ho khetholloang ke li-eosinophils tse phahamisitsoeng maling le / kapa ho phahamisoa ha nitric oxide (FeNO), ba sa laoleheng ka mokhoa o lekaneng ho isa bohareng. tekanyo e phahameng ea inhaled corticosteroids (ICS) hammoho le sehlahisoa se seng sa meriana bakeng sa phekolo ea tlhokomelo.
George D. Yancopoulos o itse: "Kamohelo ea kajeno Europe e hlokomela melemo ea Dupixent ka ho thusa bana ba phelang le liphello tse tebileng tsa asthma e matla, ho kopanyelletsa le tlhaselo e sa lebelloang ea asthma, ho sitisoa ho tloaelehileng mesebetsing ea letsatsi le letsatsi le tšebeliso ea li-systemic steroids tse ka sitisang khōlo ea bana," ho boletse George D. Yancopoulos. , MD, Ph.D., Mopresidente le Ofisiri e ka Sehloohong ea Saense ho Regeneron. "Dupixent ke eona feela kalafo e teng e thibelang ka ho hlaka lintho tse peli tse ka sehloohong tsa ho ruruha ha mofuta oa 2, IL-4 le IL-13, tseo liteko tsa rona li bonts'ang hore li na le karolo e kholo ho asthma ea bongoana, hammoho le maemong a amanang le ona a kang rhinosinusitis e nang le nko. polyposis le boemo boo hangata bo amanang le co-morbid, dermatitis ea atopic. Litekong tsa bongaka, Dupixent e fokolitse tlhaselo ea asthma haholo, e thusitse bana ho hema hamolemo le ho ntlafatsa bophelo ba bona bo amanang le bophelo bo botle. Re boetse re ikemiselitse ho etsa lipatlisiso tsa Dupixent maemong a mang moo ho ruruha ha mofuta oa 2 ho ka amang bophelo ba bakuli haholo, ho kenyelletsa eosinophilic esophagitis, prurigo nodularis le urticaria e sa foleng.
Asthma ke e 'ngoe ea mafu a sa foleng a atileng haholo baneng. Ho fihlela ho 85% ea bana ba nang le asthma ba ka ba le mofuta oa 2 oa ho ruruha mme ba na le monyetla oa ho ba le moroalo o phahameng oa mafu. Ho sa tsotellehe ho phekoloa ka ICS ea morao-rao ea tlhokomelo le li-bronchodilator, bana bana ba ka 'na ba tsoela pele ho ba le matšoao a tebileng a kang ho khohlela, ho hema le ho hema ka thata. Asma e matla e ka ama tsela ea moea ea bana e ntseng e hola 'me ea baka ho mpefala ho ka behang bophelo kotsing. Bana ba nang le asthma e matla le bona ba ka hloka ts'ebeliso ea lithupelo tse ngata tsa systemic corticosteroids tse nang le likotsi tse kholo. Asma e matla e sa laoleheng e ka sitisa mesebetsi ea letsatsi le letsatsi, joalo ka ho robala, ho ea sekolong le ho bapala lipapali.
Dupixent, e qapiloeng ho sebelisoa thekenoloji ea Regeneron ea VelocImmune®, ke anti-monoclonal antibody ka ho feletseng e thibelang pontšo ea litsela tsa interleukin-4 (IL-4) le interleukin-13 (IL-13) 'me ha se se thibelang ho itšireletsa mafung. Ka ho bonts'a melemo ea bohlokoa ea kliniki hammoho le ho fokotseha ha mofuta oa 2 ho ruruha ka mor'a thibelo ea IL-4 le IL-13 le Dupixent, lenaneo la bongaka la Dupixent Phase 3 le fumane hore IL-4 le IL-13 ke bakhanni ba ka sehloohong ba ho ruruha ha mofuta oa 2. e na le karolo e kholo ho mafu a mangata a amanang le a atisang ho ama 'moho ao Dupixent e amoheloang ho ona ho kenyeletsa asthma, atopic dermatitis le chronic rhinosinusitis e nang le nasal polyposis (CRSwNP), hammoho le mafu a lipatlisiso a kang eosinophilic esophagitis le prurigo nodularis, tse ithutoang. litekong tsa Mokhahlelo oa 3.
"Re thabetse ho tlisa boemo bo tsitsitseng ba polokeho le katleho ea Dupixent ho bakuli ba banyenyane ba nang le asthma e matla e sa laoleheng Europe. Ntle le ho fokotsa haholo litlhaselo tse matla tsa asthma le ho ntlafatsa ts'ebetso ea matšoafo, bakuli litekong tsa rona tsa bongaka le bona ba fokolitse tšebeliso ea bona ea molomo oa corticosteroid. Sena se na le moelelo ka ho khetheha kaha tsena ke meriana e ka behang likotsi tse kholo tsa tšireletso haeba e sebelisoa nako e telele, "ho boletse Naimish Patel, MD Hlooho ea Global Development, Immunology le Inflammation Sanofi. "Kamohelo ena e totobatsa boitlamo ba rona bo tsoelang pele ba ho tlisa Dupixent ho bakuli ba bangata kamoo ho ka khonehang ba nang le litlamorao tse mpe tsa asthma e matla ka tšepo ea ho ntlafatsa bophelo ba bona."
Qeto ea EC e ipapisitse le lintlha tsa bohlokoa tse tsoang tekong ea Phase 3 VOYAGE e hlahlobang katleho le polokeho ea Dupixent e kopantsoeng le kalafo e tloaelehileng ea asthma ho bana ba 408 ba nang le asthma e mahareng ho isa ho e matla e sa laoleheng.
Batho ba babeli ba boletsoeng esale pele ba nang le bopaki ba ho ruruha ha mofuta oa 2 ba ile ba hlahlojoa bakeng sa tlhahlobo ea mantlha: bakuli ba 1) ba nang le li-eosinophils tsa mali (EOS) ≥300 lisele / μl (n = 259) le 2) bakuli ba nang le karolo ea motheo ea FeNO ≥20 limilione tse likete (ppb) kapa mali a motheo EOS ≥150 lisele / μl (n = 350). Bakuli ba kentseng Dupixent tlhokomelong e tloaelehileng lihlopheng tsena tse peli, ka ho latellana, ba bile le boiphihlelo:
• Litefiso tse fokotsehileng haholo tsa tlhaselo e matla ea asthma, ka 65% le 59% ea ho fokotseha ha karolelano ho feta selemo se le seng ha ho bapisoa le placebo (liketsahalo tsa 0.24 le 0.31 ka selemo bakeng sa Dupixent vs. 0.67 le 0.75 bakeng sa placebo, ka ho latellana).
• Tshebetso e ntlafetseng ya matshwafo e hlokometswe pele ho dibeke tse pedi le ho tshwarella ho fihla dibeke tse 52, ho lekanngwa ka diphesente tse lekanyeditsweng FEV1 (FEV1pp).
• Ka libeke tse 12, bakuli ba noang Dupixent ba ile ba ntlafatsa tšebetso ea matšoafo a bona ka 5.32 le 5.21 lekholong ha ba bapisoa le placebo, ka ho latellana.
• Taolo e ntlafetseng ea asthma, le 81% le 79% ea bakuli ba tlaleha ntlafatso e nang le moelelo oa tleliniki libeke tsa 24, ho itšetlehile ka matšoao a lefu le phello ho bapisoa le 64% le 69% ea bakuli ba placebo, ka ho latellana.
• Bophelo bo ntlafetseng bo amanang le bophelo bo botle, le 73% le 73% ea bakuli ba tlaleha ntlafatso e nang le moelelo oa tleliniki libeke tsa 24, ha ba bapisoa le 63% le 65% ea bakuli ba placebo, ka ho latellana.
• Ho fokotsa tšebeliso ea systemic corticosteroid ka karolelano ea 66% le 59% nakong ea selemo se le seng ha ho bapisoa le placebo (lithuto tsa 0.27 le 0.35 ka selemo bakeng sa Dupixent vs. 0.81 le 0.86 bakeng sa placebo, ka ho latellana).
Liphetho tsa polokeho ho tsoa tekong hangata li ne li lumellana le boemo bo tsebahalang ba polokeho ea Dupixent ho bakuli ba lilemo tse 12 ho ea holimo ba nang le asthma e sa laoleheng ho isa ho e matla. Kakaretso ea litekanyetso tse mpe e ne e le 83% bakeng sa Dupixent le 80% bakeng sa placebo. Liketsahalo tse mpe tse neng li bonoa hangata ka Dupixent ha li bapisoa le placebo li ne li kenyelletsa karabelo ea sebaka sa ente (18% Dupixent, 13% placebo), mafu a tšoaetso ea kokoana-hloko e kaholimo ea phefumoloho (12% Dupixent, 10% placebo) le eosinophilia (7% Dupixent, 1% placebo). ). Ts'oaetso ea Helminth e ne e boetse e bonoa hangata ka Dupixent ho bakuli ba lilemo tse 6 ho isa ho tse 11 mme ho tlalehiloe ho 2% ea bakuli ba Dupixent le 0% ea bakuli ba placebo.
SEO U LOKELANG HO SE NKA HO SEHLOOHO ENA:
- 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,”.
