Bomba la mankhwala likuphatikizapo gulu la mankhwala omwe ali pa chitukuko pa nthawi iliyonse ndi makampani osiyanasiyana a mankhwala. Mankhwalawa mumayipi amapita ku magawo 4 akuluakulu: kupeza, chithandizo chamankhwala, chithandizo chamankhwala, ndi malonda (zomwe zimachitika pambuyo pa kuvomerezedwa).
Pali madokotala okwana 5,000 omwe akutsogoleredwa lero ku United States okha pazochitika zosiyanasiyana.
Ochita kafukufuku amayesetsa kupanga mankhwala osokoneza bongo kwa odwala omwe ali ndi zosowa zosayenera. Malingana ndi PhRMA (The Pharmaceutical Research and Manufacturers of America), "Mu 2014, US Food and Drug Administration (FDA) inavomereza mankhwala atsopano 51 m'madera ambiri a matenda. Zomwe makumi asanu ndi limodzi mwazovomerezedwazo zinali ndi Center for Drug Kufufuza ndi Kafukufuku (CDER) ku FDA, chiwerengero chachikulu kwambiri kuyambira mu 1996. Pakati pa ma CDER, 41 peresenti amadziwika kuti ndi mankhwala oyamba, kutanthauza kuti amagwiritsa ntchito njira yapadera yochizira matenda omwe ali osiyana ndi mankhwala ena ovomerezeka. "
Kupanga Mankhwala Opatsirana Amagazi
Kuyambira m'chaka cha 1998, pamene Enbrel (etanercept) inali mankhwala oyamba odwala matenda a nyamakazi , nyamakazi ya DMARD (biologic-modifying anti-rheumatic drugs) inasintha malo ochizira anthu omwe ali ndi matendawa. Pogwiritsa ntchito ma molekyulu ndi maselo omwe ali ndi matenda a nyamakazi, nyamakazi ya DMARD ndi ma DMARD atsopano, omwe amadziwika kuti JAK inhibitors, athandiza odwala ambiri kuti adziwe kuti ali ndi vutoli .
DMARD yambiri ya biologic yavomerezedwa ndi kugulitsidwa zaka zotsatirazi zikuvomerezedwa ndi Enbrel. Enbrel ndi TNF inhibitor . Zitsanzo zina za TNF zotetezedwa pakali pano ndi Remicade (infliximab), Humira (adalimumab), Cimzia (certolizumab pegol), ndi Simponi (golimumab). Pakhala pali JAK inhibitor imodzi yomwe inavomerezedwa, mu 2012, yotchedwa Xeljanz (tofacitinib) .
Ma DMARD ambiri ali pa chitukuko.
DMARD ya biologic ndi zazikulu zamapuloteni zomwe zimayenera kuikidwa kapena kuikidwa. JAK inhibitors ndi mapuloteni ang'onoang'ono a molekyulu omwe amaperekedwa pamlomo (pakamwa).
Mu 2014, PhRMA inanena kuti mankhwala okwana 92 anali mu magawo osiyanasiyana a chitukuko cha matenda a minofu . Mwa iwo, 55 anali kupangidwa kuti apange mankhwala a nyamakazi. Ndi mankhwala omwe amafikira mayesero amachilendo a Phase 3 omwe ndi ofunikira kwambiri. Kuyeza kwachigawo chachitatu kumaphatikizapo odwala oposa 1,000 pofuna kuyesa kutetezeka ndi kuchitapo kanthu. Zotsatira zafotokozedwa kwa FDA pofuna kuvomereza mankhwala omaliza.
Kodi ndi Pipeni yotani?
Baricitinib ndi JAK inhibitor yopititsa patsogolo kudzera mwa Eli Lilly. Ngati izo zivomerezedwa, Baricitinib idzakhala yachiwiri JAK inhibitor yovomerezeka. Baricitinib imatseka JAK1 ndi JAK2. Kuchiza ndi JAK inhibitors kumapangidwira anthu akuluakulu omwe ali ndi mphamvu yogwira nyamakazi yovuta kwambiri yomwe imakhala ndi yankho lokwanira kwa methotrexate kapena amene sangathe kulekerera methotrexate. Baricitinib ali ndi mwayi wovomerezeka wa 65 peresenti, malinga ndi katswiri wina. Ngati kuvomerezedwa, akuyenera kuti apikisane ndi mpikisano wake Xeljanz, malingana ndi mitengo.
Sarilumab ndi IL-6 inhibitor yopangidwa ndi Sanofi / Regeneron. Pali mayesero atatu omwe akuyambira sarilumab. Mmodzi mwa mayeserowa, sarilumab kuphatikizapo methotrexate inali yothandiza kwambiri kwa odwala omwe ali ndi vuto la nyamakazi yovuta kwambiri kusiyana ndi methotrexate yekha, popanda nkhawa iliyonse. Mankhwalawa, ngati avomerezedwa, adzakangana ndi wina IL-6 inhibitor, Actemra (tocilizumab).
Secukinumab ndi njira ya IL-17 inhibitor yopangidwa ndi Novartis Pharmaceuticals. Secukinumab imagwiritsidwa ntchito kwa odwala matenda a nyamakazi omwe sankagwirizana ndi TNF inhibitors kapena omwe sanathe kulekerera chithandizo ndi TNF.
Pakalipano palibe mankhwala ena omwe amagwira IL-17 mu njira yotupa .
Chilombo china choyembekezera, Johnson & Johnson's sirukumab, chinatsutsidwa ndi FDA mu September 2017. Imafuna njira yomweyo monga ACTEMRA (IL-6), kuthandiza kuchepa kutupa. Komabe, a FDA adatchula "kusamvetsetsana" pa chiwerengero cha imfa za anthu omwe amamwa mankhwalawa ndi malo omwe akuyesedwa, malo omwe poyamba adalangizidwa mu ndondomeko ya uphungu wa FDA .
Akatswiri
Palinso akatswiri ochepa a zamoyo pa chitukuko. Amgen akukulitsa ABP 501, biyosimilar kwa Humira. Boehringer Ingelheim Pharmaceuticals ikukula BI 695500 monga Rituxan (rituximab) biosimilar. Coherus Biosciences ikukula CHS-0214 monga Enbrel biosimilar. Pali nkhawa yokhudzana ndi kugwiritsira ntchito mankhwala osokoneza bongo kwa mankhwala oyambirira, komanso njira yovomerezeka ya FDA yokhala ndi zamoyo.
> Zotsatira:
> Buku la FDA Briefing. Msonkhano wa Komiti Yogonana ndi Amuna.
> PhRMA.2015 Mbiri. Biopharmaceutical Research Industry.
> Regeneron ndi Sanofi Panopa Zotsatira za Zopindulitsa Gawo 3 Phunziro la Sarilumab ku Msonkhano Wapachaka wa American College wa Rheumatology. November 8, 2015.
> Chifuwa chachikulu cha nyamakazi (RA) Pipangizo yatsopano ya mankhwala osokoneza bongo. December 11, 2014.