Iphayiphi yezidakamizwa iqukethe iqembu lezidakamizwa ezithuthukisiwe nganoma isiphi isikhathi ngezinkampani ezihlukahlukene zemithi. Imithi emgqeni ihamba ngezigaba ezine eziyinhloko: ukutholakala, ukuhlolwa ngaphambili, ukuhlolwa kwemitholampilo, nokumaketha (okwenzeka ngemuva kokuvunywa).
Kukhona izidakamizwa ezingaba ngu-5 000 ekuthuthukiseni namuhla e-United States kuphela ngezimo ezihlukahlukene.
Abacwaningi balwela ukuthuthukisa izidakamizwa ezigulini ezinezidingo ezingapheli. Ngokusho kwe-PhRMA (i-Pharmaceutical Research and Manufacturers of America), "Ngo-2014, i-US Food and Drug Administration (FDA) yavuma imithi emisha engu-51 kuyo yonke indawo yezifo eziningi. Ukuhlola Nokucwaninga (CDER) ku-FDA, inombolo ephakeme kunazo zonke kusukela ngo-1996. Phakathi kokugunyazwa kwe-CDER, amaphesenti angu-41 abhekwa njengamayeza okuqala-ekilasini, okusho ukuthi basebenzisa indlela ehlukile yokusebenza ukuze baphathe isimo sezokwelapha esihlukile kunoma yikuphi enye imithi evunyelwe. "
Ukuthuthukisa izidakamizwa ze-Rheumatoid Arthritis
Kusukela ngo-1998, ngenkathi i- Enbrel (etanercept) yikhambi lokuqala le- biologic elidayiswe nge- rheumatoid arthritis , i-biologic DMARDs (i-biologic-modifying anti-rheumatic drugs) yashintsha indawo yokwelapha yabantu abaphila nesifo. Ngokukhomba amakhemikhali namaseli athile abathintekayo ekuqhubekeleni kwe-arthritis ye-rheumatoid, i-DMARD ye-biologic kanye ne-DMARD emisha, eyaziwa ngokuthi i-JAK inhibitors, ithuthukise ukubikezela iziguli eziningi futhi yenza abanye bakwazi ukuxolelwa ngamakliniki .
I-DMARD eziningana ze-biologic zamukelekile futhi zithengiswa eminyakeni elandelayo yokuvuma kuka-Enbrel. I-Enbrel yi- inhibitor ye-TNF . Ezinye izibonelo ze-TNF inhibitors okwamanje zithengiswa yi-Remicade (i-infliximab), i-Humira (i-adalimumab), i-Cimzia (i-certolizumab pegol), ne-Simponi (i-golimumab). Kuye kwaba ne-JAK inhibitor eyodwa evunyelwe, ngo-2012, ebizwa nge- Xeljanz (tofacitinib) .
Ama-DMARD amaningi asekuthuthukisweni.
I-DMARD ye-biologic yizinhlayiya ezinkulu zamaprotheni okumele zijowe noma zifakwe. Ama-JAK inhibitors ama-proteins amancane amancane asetshenziswa ngomlomo (ngomlomo).
Ngo-2014, i-PhRMA ibike ukuthi izidakamizwa ezingu-92 zazingezindlela ezihlukene zokuthuthukiswa kwezifo nezimo ze- musculoskeletal . Kulabo, kwakhiwa ama-55 ekwelapheni i-rheumatoid arthritis. Yizidakamizwa ezifinyelela ezivivinyweni zomtholampilo zeSigaba 3 ezifanele kakhulu ukunakwa kwethu. Ukuhlolwa kwesigaba sesi-3 kubandakanya iziguli ezingaphezu kuka-1 000 ngomzamo wokufakazela ukuphepha nokusebenza. Imiphumela ihanjiswa kwi-FDA yokuthola izidakamizwa zokugcina.
Kuyini kuPayipi?
I-Baricitinib yi-JAK inhibitor ekuthuthukiseni ngo-Eli Lilly. Uma kuvunyelwe, i-Baricitinib izoba yesibili i-JAK inhibitor evunyelwe. I-Baricitinib ivimbela i-JAK1 ne-JAK2. Ukwelapha nge-JAK inhibitors kuhloswe ukuthi abantu abadala bahlolisise isifo samathambo esibucayi esisebenza kahle abaye basabela ngokungafanele emettretrexate noma abangakwazi ukubekezelela i-methotrexate. I-Baricitinib inamathuba angu-65 wamaphesenti okuvunyelwa, ngokusho komcwaningi othile. Uma kuvunyelwe, kulindeleke ukuba ukuncintisane nomncintiswano wayo Xeljanz, kuye ngokwezindleko.
I-Sarilumab iyi-IL-6 inhibitor eyenziwa nguSanofi / Regeneron. Kunezilinganiso eziningana zesigaba 3 ezenzekayo ku-sarilumab. Kwesinye sezilingo, i-sarilumab kanye ne-methotrexate yayiphumelele kakhulu ezigulini ezinomqondo olinganiselwe wesifo se-rheumatoid esiyingozi kune-methotrexate yedwa, ngaphandle kokukhathazeka okubonakalayo kokuphepha. Lesi sidakamizwa, uma sivunyiwe, sizokwazi ukuncintisana nezinye i-IL-6 inhibitor, i-Actemra (tocilizumab).
I-Secukinumab iyi-IL-17 inhibitor eyenziwa yi-Novartis Pharmaceuticals. I-Secukinumab ihloselwe iziguli ezine-arthritis ye-rheumatoid ezingaba ne-response enganele nge-TNF inhibitors noma abangakwazi ukubekezelela ukwelashwa nge-TNF inhibitors.
Okwamanje akakho omunye umuthi ohlose i-IL-17 endleleni yokuvuvukala .
Esinye isidakamizwa esilindelwe, sirukumab sikaJohnson & Johnson, senqatshelwe ukuvunyelwa yi-FDA ngoSepthemba 2017. Sibheke indlela efanayo ne-ACTEMRA (IL-6), okusiza ukunciphisa ukuvuvukala. Kodwa-ke, i-FDA ibhekisele "ukungalingani" ngenani lokufa kwabantu abathwala izidakamizwa ngokumelene ne-placebo ekuvivinyweni, isikhundla esasikhululwe ekuqaleni kwinconywa yephaneli le- FDA weluleko .
Biosimilars
Kukhona futhi ama-biosimilars ambalwa ekuthuthukisweni. U-Amgen uthuthukisa i-ABP 501, i-biosimilar ku-Humira. I-Boehringer Ingelheim Pharmaceuticals ithuthukisa i-BI 695500 njenge-Rituxan (rituximab) biosimilar. I-Coherus Biosciences ithuthukisa i-CHS-0214 njenge-Enbrel biosimilar. Kukhona ukukhathazeka mayelana nokulinganisa kwemikhiqizo ye-biosimilar kwisidakamizwa sokuqala, kanye nenqubo yokugunyazwa ye-FDA yezinhlobo zezinto eziphilayo.
> Imithombo:
> Idokhumenti ye-FDA Briefing. Umhlangano weKomidi Elibucayi Le-Arthritis.
> PhRMA.2015 Umlando. Industry Industry Research.
> I-Regeneron ne-Sanofi I-Current Results kusuka eSigaba Esiyinhloko Isifundo SakwaSarilumab eMhlanganweni Wonyaka We-American College of Rheumatology. Ngo-Novemba 8, 2015.
> I-Rheumatoid Arthritis (RA) Iphayiphu entsha yeDrug. Ngo-Disemba 11, 2014.