Pipe ea lithethefatsi e na le sehlopha sa lithethefatsi tse tsoelang pele ka nako leha e le efe ka lik'hamphani tse sa tšoaneng tsa meriana. Lithethefatsi ka liphaephe li feta mekhalong e mabeli e meholo: ho sibolloa, pele ho meriana, liteko tsa meriana, le papatso (e etsahalang ka mor'a hore e amohelehe).
Ho na le lithethefatsi tse ka bang 5 000 ntshetsopele kajeno United States feela bakeng sa maemo a sa tšoaneng.
Bafuputsi ba leka ho hlahisa lithethefatsi bakeng sa bakuli ba nang le litlhoko tse sa lekanyetsoang. Ho ea ka PhRMA (The Pharmaceutical Research and Manufacturers of America), "Ka 2014, US Administration and Drug Administration (FDA) e amohetse meriana e mecha e 51 holima libaka tse sa tšoaneng tsa maloetse. Li-40 tsa tsona li ne li amoheloa ke Setsi sa Lithethefatsi Tlhahlobo le Lipatlisiso (CDER) ho FDA, palo e phahameng ka ho fetisisa ho tloha ka 1996. Har'a litumello tsa CDER, karolo ea 41 lekholong e ile ea khethoa e le meriana ea pele-ka-likarolo, e bolelang hore e sebelisa mekhoa e ikhethang ea ho nka phekolo ea meriana e fapaneng le efe kapa efe moriana o mong o amohelehang. "
Ho Hlahisa Rheumatoid Ramatiki ea Lithethefatsi
Ho tloha ka 1998, ha Enbrel (etanercept) e ne e le lithethefatsi tsa pele tsa biologic tse rekisoang ke ramatiki ea ramatiki , li-DMARD tsa likokoana-hloko (likokoana-mafu tse fetoletsoeng ke lefu la biologic) li fetohile sebaka sa phekolo bakeng sa batho ba phelang le lefu lena. Ka ho lebisa limolek'hule le lisele tse amanang le tsoelo-pele ea ramatiki, li-DMARD tsa biologic le li-DMARD tse ncha, tse tsejoang e le JAK inhibitors, li ntlafalitse matšoao bakeng sa bakuli ba bangata 'me li etsa hore ba bang ba khone ho fokolloa .
DMARD tse 'maloa tsa biologic li amoheloa le ho rekisoa lilemong tse latelang ka tumello ea Enbrel. Enbrel ke TNF inhibitor . Mehlala e meng ea TNF inhibitors e rekisoang ke Remicade (infliximab), Humira (adalimumab), Cimzia (certolizumab pegol), le Simponi (golimumab). Ho bile le JAK inhibitor e amohelehang, ka 2012, e bitsoang Xeljanz (tofacitinib) .
DMARD e mengata e nts'etsopele.
Li-DMARD tsa biologic ke li-protein tse khōlō tse lokelang ho kenngoa kapa ho kenngoa. JAK inhibitors ke liprotheine tse nyenyane tsa molek'hule tse sebelisoang ka molomo (ka molomo).
Ka 2014, PhRMA e tlalehile hore lithethefatsi tse 92 li ne li le likarolong tse fapaneng tsa nts'etso-pele ea maloetse a masiana le maemo. Har'a tsona, ho ne ho hahoa tse 55 bakeng sa phekolo ea ramatiki ea lefu la bokooa. Ke lithethefatsi tse fihlellang liteko tsa kliniki ea Phase 3 tseo re lokelang ho li ela hloko ka ho fetisisa. Tlhahlobo ea phalliso ea bobeli e atisa ho ba le bakuli ba fetang 1 000 ho leka ho netefatsa tšireletseho le katleho. Liphetho li hlahisoa ho FDA bakeng sa tumello ea ho qetela ea lithethefatsi.
Ke eng ka Pipeline?
Baricitinib ke JAK inhibitor ho nts'etsopele ka Eli Lilly. Haeba e amoheleha, Baricitinib e tla ba ea bobeli JAK inhibitor e amohelehang. Baricitinib e thibela JAK1 le JAK2. Kalafo le JAK inhibitors e etselitsoe batho ba baholo ba nang le ramatiki e nang le matla a lefu la sebete a sebetsang ka tsela e lekaneng ho feta ea methatrexate kapa ba sitoang ho mamella methotrexate. Baricitinib e na le menyetla ea 65 lekholong ea ho amoheloa, ho latela setsebi se seng. Haeba e amoheleha, ho lebeletsoe hore e be tlhōlisano khahlanong le mohatelli oa eona Xeljanz, ho itšetlehile ka litefiso.
Sarilumab ke IL-6 inhibitor e hlahisoang ke Sanofi / Regeneron. Ho na le liteko tse 'maloa tsa likarolo tse ntseng li tsoela pele bakeng sa sarilumab. Har'a e 'ngoe ea liteko, sarilumab hammoho le methotrexate e ne e sebetsa haholo ho bakuli ba nang le ramatiki e feteletseng ho feta methotrexate feela, ho se na mathata a bonahalang a sireletsehileng. Meriana ena, haeba e amoheleha, e tla hlōlisana le e 'ngoe IL-6 inhibitor, Actemra (tocilizumab).
Secukinumab ke IL-17 inhibitor e hlahisoang ke Novartis Pharmaceuticals. Secukinumab e etselitsoe bakuli ba nang le ramatiki ea lefu la masapo ba neng ba e-na le karabelo e lekaneng ea TNF inhibitors kapa ba neng ba sa khone ho mamella phekolo ka TNF inhibitors.
Hona joale ha ho na lithethefatsi tse ling tse hlaselang IL-17 ka tsela ea ho ruruha .
E 'ngoe ea lithethefatsi e lebelloang, sirukumab ea Johnson & Johnson, e hanneloa ke tumello ea FDA ka September 2017. E ipehela tseleng e tšoanang le ACTEMRA (IL-6), e thusang ho fokotsa ho ruruha. Leha ho le joalo, FDA e boletse "ho se leka-lekane" palo ea batho ba shoang ba nang le lithethefatsi ho latela sebaka sa placebo litekong, boemo bo hlalositsoeng qalong tlhahiso ea sehlopha sa keletso ea FDA .
Li-biosimilars
Hape ho na le li-biosimilar tse 'maloa ho nts'etsopele. Amgen o ntse a hōlisa ABP 501, e leng tlhahiso ea liphatlalatso ho Humira. Boehringer Ingelheim Pharmaceuticals e ntshetsa pele BI 695500 e le Rituxan (rituximab) biosimilar. Coherus Biosciences e ntse e hōla le CHS-0214 e le sebopeho sa Enbrel. Ho na le ho ameha ka ho lekanngoa ha lihlahisoa tsa lihlahisoa tsa tlhaho le lithethefatsi tsa pele, hammoho le ts'ebetso ea FDA ea tumello ea lihlahisoa tsa tlhaho.
> Mehloli:
> Tokomane ea FDA Briefing. Seboka sa Komiti ea Boeletsi ba Ramatiki.
> PhRMA.2015 Profile. Biopharmaceutical Research Industry.
> Regeneron le Sanofi Phello e hlahang ho Thuto ea Bohlokoa ea 3 ea Sarilumab Kopanong ea selemo le selemo ea American College of Rheumatology. La 8 November, 2015.
> Ramatiki ea Ramatiki (RA) Pipeline e Ncha ea Lithethefatsi. La 11 December, 2014.