Qalabka maandooriyuhu wuxuu ka kooban yahay koox daawooyin ah oo ku jira horumarinta wakhti kasta oo ay bixiyaan shirkado daawooyin oo kala duwan. Daawooyinka dhuumuhu waxay marayaan 4 marxaladood oo waaweyn: helitaan, tijaabo hore, kiliinikada tijaabada, iyo suuqgeynta (taas oo dhacda kadib marka la ansixiyo).
Waxaa jira qiyaastii 5,000 oo daawo ah horumarinta maanta ee Maraykanka oo keliya xaalado kala duwan.
Cilmi-baadhayaashu waxay ku dadaalaan inay horumariyaan mukhaadaraadka bukaannada leh baahiyo aan la daboolin Sida laga soo xigtay PhRMA (Cilmi-baarista Pharmaceuticals and Manufacturers of America), "2014-kii, Maamulka Cuntada iyo Dawooyinka ee Maraykanka (FDA) ayaa 51 oggolaaday daawo cusub oo ku baahsan goobo kala duwan oo cudurro ah, kow iyo mid ka mid ah kuwa la ansixiyay waxaa ka mid ahaa Xarunta Maandooriyaha Qiimaynta iyo Cilmi-baarista (CDER) ee FDA, lambarka ugu sareeya tan iyo 1996-kii. Cilmi-baarista CDER, 41 boqolkiiba ayaa loo aqoonsaday inay yihiin daawooyinka fasalka koowaad, taasoo micnaheedu yahay inay isticmaalaan hab farsamo oo ficil ah si loo daaweeyo xaalad caafimaad oo ka duwan mid kasta dawooyinka kale ee la ansixiyay. "
Horumarinta Dawooyinka Rheumatoid Xabashida
Laga soo bilaabo 1998, markii Enbrel (etanercept) uu ahaa daroogada ugu horeysa ee nafaqada ah ee lagu iibiyo rheumatoid arthritis , DMONs biologiska (cudurada biology-wax ka beddelaya daawooyinka ladagaallanka rheumatiska) ayaa bedelay muuqaalka daaweynta dadka qaba cudurka. By bartilmaameedyada molecules gaarka ah iyo unugyada ku lug leh horumarka rheumatoid arthritis, DMONs biologiska iyo DMARD cusub, oo loo yaqaan 'JAK inhibitors', waxay kor u qaadeen saadaalinta bukaanno badan oo ka dhigay qaar ka mid ah bukaanka remission suurto gal ah.
Qaar badan oo ka mid ah DMONs biologiska ayaa la ansixiyay oo la iibiyey sanooyin kadib markii la ansaxiyey Enbrel. Enbrel waa ka hortag TNF ah . Tusaalooyinka kale ee ka hortagga TNF ee hadda suuqa waa Remicade (infliximab), Humira (adalimumab), Cimzia (certolizumab pegol), iyo Simponi (golimumab). Waxaa jirey hal JAK inhibitor la ansixiyay, 2012-kii, loo yaqaan Xeljanz (tofacitinib) .
DMARDs badan ayaa ku jira horumarinta.
DMARD-yahannada bayoolojiga ah waa borotiinno badan oo la yiraahdo molecule proteins kaas oo ah in lagu mudo ama la faafiyo. JAK-celiyeyaasha JAK waa borotiinno yaryar oo yaryar oo loo isticmaalo afka (afka).
Sannadka 2014, PhRMA waxay soo warisay in 92 daroogo ay ku jiraan marxalado kala duwan oo ah horumarinta cudurrada muruqyada iyo xaaladaha. Dadkaas, 55 ayaa loo sameeyay si loogu daaweeyo rheumatoid arthritis. Waa daawooyinka soo gaara tijaabooyinka 3aad ee kiliiniga kuwaas oo ah kuwa ugu mudan mudnaanta leh. Baadhitaanka Wajiga 3 wuxuu caadi ahaan ku lug leeyahay in ka badan 1,000 bukaanno si loo xaqiijiyo amniga iyo waxtarka. Natiijooyinka waxaa loo soo bandhigayaa FDA si ay u ansaxiso mukhaadaraadka ugu dambeeya.
Maxaa ku jira Pipeline?
Baricitinib waa JAK hortaagan horumarinta iyadoo loo marayo Eli Lilly. Haddii la ansaxiyo, Baricitinib wuxuu noqonayaa kii labaad ee JAK ee la ansixiyay. Baricitinib blocks JAK1 iyo JAK2. Daaweynta Cudurka JAK waxaa loogu talagalay dadka qaangaarka ah ee leh rheumatoid arthritis-firfircoon oo dhexdhexaad ah iyo kuwo aad u daran kuwaas oo ku yeeshay jawaab aan ku filnayn methotrexate ama aan u dulqaadan karin daawada methotrexate. Baricitinib wuxuu haystaa fursad boqolkiiba 65 ah oo oggolaansho ah, sida uu qabo falanqeeyaha. Haddii la ansixiyo, waxaa la filayaa in uu tartan ka dhan yahay tartanka tartanka Xeljanz, iyadoo ku xiran qiimaha.
Sarilumab waa IL-6 inhibitor ah oo ay sameeyaan Sanofi / Regeneron. Waxaa jira wajiyo dhowr marxaladood oo tijaabo ah oo loogu talagalay sarilumab. Mid ka mid ah tijaabooyinka, sarilumab iyo daawada methotrexate waxay u fiicnayd bukaanka qaba arthritis-ka dhexdhexaad ah iyo mid daran oo ka badan methotrexate oo keliya, iyada oo aan jirin wax welwel ah oo ammaan ah. Daroogadaas, haddii la ansixiyo, waxay la tartami doontaa IL-6 inhibitor kale, Actemra (tocilizumab).
Secukinumab waa IL-17 inhibitor ah oo ay sameeyaan Pharmaceuticals Novartis. Secukinumab waxaa loogu talagalay bukaanada qaba rheumatoid arthritis kuwaas oo aan ku filneyn jawaab celin TNF ah ama aysan awoodin in ay u dulqaataan daaweynta TNF.
Ma jiraan wax kale oo daroogo ah oo bartilmaameedsanaya IL-17 oo ah dariiqa bararsan .
Daroogada kale ee la filayo, Johnson & Johnson's sirukumab, ayaa loo diiday inay ansaxiso FDA bishii Sebtembar 2017. Waxay bartilmaameed ka dhigtaa wadada ACTEMRA (IL-6), oo gacan ka gaysata joojinta caabuqa. Si kastaba ha ahaatee, FDA waxay ku qortay "isku dheelitir" tirada dhimashada dadka qaatay daroogada ka soo horjeeda xudduudaha tijaabooyinka, oo ah asal ahaan asal ahaan lagu soo koobay talo-bixinta guddiga talabixinta FDA .
Biosimilars
Waxaa sidoo kale jira dhowr biosimilar ah horumarinta. Amgen waa horumarinta ABP 501, oo ah biosimilar ku socota Humira. Boehringer Ingelheim Pharmaceuticals waxay horumarinaysaa BI 695500 oo ah Rituxan (rituximab) biosimilar. Xirfadlaha Daraasaadka (Biological Sciences) wuxuu horumarinayaa CHS-0214 oo ah habka Biosimilar. Waxaa jira walaac ku saabsan isku dheelitirka alaabooyinka biosimilar ee daawada asaasiga ah, iyo sidoo kale habka oggolaanshaha FDA ee biosimilars.
> Ilo:
> Diiwaangelinta FDA. Kulanka La-talinta Guddiga La-talinta Arthritis.
> Khariidadda PhRMA2015. Warshadaha Cilmi-baarista Fayliska.
> Regeneron iyo Sanofi Natiijooyinka Heerka Sare ee Barashada Wajiga 3aad ee Sarilumab ee Kuleejka American College of Rheumatology. Nofeembar 8, 2015.
> Rheumatoid Arthritis (RA) Khamriga cusub ee Dawada. Diisambar 11, 2014.