Iipilisi zamachiza zibandakanya iqela leziyobisi eziphuhliswayo nayiphi na ixesha ngeenkampani ezahlukeneyo zokuxuba. Amachiza epayipi ahamba kwiinqanaba ezi-4 eziphambili: ukufumanisa, i-pre-clinical, uvavanyo lweeklinikhi kunye nokuthengisa (okwenzeka emva kokuvunywa).
Kukho amayeza angama-5,000 ekuphuhlisweni namhlanje eMelika kuphela yimiqathango eyahlukeneyo.
Abaphandi bazama ukuphuhlisa iziyobisi kwizigulane ezinesidingo esingenasiphelo. Ngokutsho kwe-PhRMA (i-Pharmaceutical Research and Manufacturers of America), "Ngo-2014, i-US Food and Drug Administration (FDA) yamkele amayeza amatsha ama-51 kwiindawo ezahlukeneyo zezifo. Ukuvandlakanywa noPhando (CDER) kwi-FDA, inani eliphakamileyo ukususela ngo-1996. Phakathi kweemvume ze-CDER, iipesenti ezingama-41 zichongiwe njengamayeza okuqala okuqala, oku kuthetha ukuba basebenzise indlela eyahlukileyo yokunyanga imeko yonyango eyahlukileyo nawuphi na elinye iyeza. "
Ukuphuhlisa izidakamizwa zeRheumatoid Arthritis
Ukususela ngo-1998, xa i- Enbrel (etanercept) yayiyilungu lokuqala lokuthengisa i- rheumatoid arthritis , i-DMARD ye-biologic (i-biologicalic-anti-rheumatic drugs) iguqule indawo yokuphathwa ngabantu abaphila nesi sifo. Ngokujoliswa kwee-molecule kunye neeseli ezibandakanyekayo ekuqhubekeni kwe-rheumatoid arthritis, i-DMARD ye-biologic kunye ne-DMARD entsha, eyaziwa ngokuba yi-JAK inhibitors, ziye zaphucula izigulane zezigulane ezininzi kwaye zenza ukuba abanye bakwazi ukuxolelwa .
Iimfuno zeDMARD ezininzi ziye zavunywa kwaye zithengiswa kwiminyaka emva kokuvuma kuka-Enbrel. Enbrel yi- TNF inhibitor . Eminye imizekelo ye-TNF inhibitors ekuthengiswayo i-Remicade (infliximab), i-Humira (adalimumab), iCimzia (certolizumab pegol), kunye ne-Simponi (golimumab). Kuye kwavunyelwa iJAK inhibitor, ngo-2012, ebizwa ngeXeljanz (tofacitinib) .
Uninzi lwe-DMARD lukuphuhliso.
I-DMARD ye-biologic iiproleyile ezinkulu ezimele zijojowe okanye zifakwe. I-JAK inhibitors zinama-molecule amancinci alawulwa ngomlomo (ngomlomo).
Ngo-2014, i-PhRMA yabika ukuba izidakamizwa ezingama-92 zazingamazinga ahlukeneyo ekuphuhliseni izifo ze-musculoskelet and conditions. Kuzo, ezingama-55 zaziye zaphuhliswa ukuze zonyango lwe-rheumatoid arthritis. Ziyiziyobisi ezifikelela kwizilingo zesigaba se-3 esilungele ukusiqwalasela. Uvavanyo lweSigaba sesi-3 lubandakanya izigulane ezingaphezulu kwe-1 000 kumzamo wokubonakalisa ukhuseleko nokusebenza. Iziphumo zihanjiswe kwi-FDA imvume yokugqibela yezidakamizwa.
Yintoni kwiPayipi?
I-Baricitinib yi-JAK inhibitor ekuphuhliseni ngo-Eli Lilly. Ukuba kuvunyelwe, iBaricitinib iya kuba yowesibili i-JAK inhibitor evunyelwe. I-Baricitinib ivimba iJAK1 ne-JAK2. Utyando kunye ne-JAK inhibitors lujoliswe kubantu abadala abanomlinganiselo othethelelekileyo kwi-arthritis ye-rheumatoid esebenzayo abaye bafumana impendulo enganeleyo kwi- methotrexate okanye abangakwazi ukunyamezela i-methotrexate. I-Baricitinib inama-65 ekhulwini amathuba okuvunywa, ngokutsho komhlalutyi omnye. Ukuba kuvunyelwe, kulindeleke ukuba ukhuphisane nomqhubi walo Xeljanz, kuxhomekeke kwixabiso.
I-Sarilumab yi-IL-6 inhibitor eyenziwa nguSanofi / Regeneron. Kukho izicwangciso eziliqela ezi-3 ezenzekayo kwi-sarilumab. Kwesinye sezilingo, i-sarilumab kunye ne-methotrexate yayiphumelele ngakumbi kwizigulane ezinomlinganiselo ohambelana ne-arthritis ezininzi zesifo se-rheumatoid kunokuba i-methotrexate yodwa, ngaphandle kokukhathazeka okukhuselekileyo. Eli gciwane, ukuba livunyiwe, liya kukhuphisana nelinye i-IL-6 inhibitor, i-Actemra (tocilizumab).
I-Secukinumab yi-IL-17 inhibitor ephuhliswa yi-Novartis Pharmaceuticals. I-Secukinumab ijoliswe kwizigulane ezine-rheumatoid arthritis ezingenampendulo enganeleyo nge-TNF inhibitors okanye abangazange bakwazi ukunyamezela unyango nge-TNF inhibitors.
Okwangoku akukho nanye izilwanyana ezijolise kwi-IL-17 kwindlela yokuvutha .
Olunye utywala olulindelekileyo, uJirsonson Johnson & Johnson's sirukumab, lwavunyelwa yi-FDA ngoSeptemba 2017. Ijolise kwindlela efanayo ne-ACTEMRA (IL-6), ekuncedeni ukunciphisa ukuvutha. Nangona kunjalo, i-FDA ibhekiselele "ukungalingani" kwinani lokufa kwabantu abathatha isicatshulwa ngokumelene ne-placebo kwizilingo, isikhundla esasichazwe ekuqaleni kwi- panel ye-panel ye- FDA yeengcebiso .
Biosimilars
Kukho iimbalwa zezinto eziphilayo ekuphuhliseni. U-Amgen uphuhliso lwe-ABP 501, i-biosimilar ku-Humira. I-Boehringer Ingelheim Amachiza aphuhlisa i-BI 695500 njengeRituxan (rituximab) biosimilar. I-Coherus Biosciences ikhula i-CHS-0214 njenge-Enbrel biosimilar. Kukho inkxalabo malunga nokulingana kwemveliso ye-biosimilar kwisiza sokuqala, kunye ne-FDA yokuvunywa kwenkqubo ye-biosimilars.
> Imithombo:
> I-FDA Briefing Document. I-Arthritis yeNtlanganiso yeKomiti yeNgcebiso yeArthritis.
> PhRMA.2015 Iprofayile. Icandelo loPhando lweBiopharmaceutical Industry.
> I-Regeneron kunye neSanofi Iziphumo ezikhoyo kwiSigaba esiPhambili Sifundo seSarilumab kwi-College of Rheumatology Yonyaka. Novemba 8, 2015.
> I-Rheumatoid Arthritis (RA) iPipeline entsha yeDrug. Disemba 11, 2014.