Chirwere chemishonga chinoumbwa neboka remishonga inenge iri mukukudziridza panguva ipi neipi nemakambani akasiyana-siyana emishonga. Iyo mishonga iri mumipayipi inoenda kuburikidza nezvikamu zvina zvikuru: kuwanikwa, kusati-kliniki, kuongororwa kwechiremba, uye kutengesa (izvo zvinoitika mushure mokubvumirwa).
Iko kune madhigirii mashanu emishonga mukuvandudzika nhasi muUnited States chete nekuda kwemamiriro akasiyana-siyana.
Vatsvakurudzi vanoedza kukudziridza zvinodhaka kune varwere vane zvinodiwa zvisina kufanira. Maererano neFRMA (the Pharmaceutical Research and Manufacturers of America), "Muna 2014, US Food and Drug Administration (FDA) yakagamuchira mishonga mishanu 51 kune dzimwe nzvimbo dzakasiyana-siyana dzezvirwere.I makumi mana-imwe yevabvumirwo iyi yaiva neCent for Drug Kuongorora nekutsvakurudza (CDER) kuDFA, nhamba yakakwirira kubva muna 1996. Pakati pemvumo yeCDER, 41 muzana vakaonekwa semishonga yekutanga-in-class, zvinoreva kuti vanoshandisa nzira yakasiyana-siyana yekuita kurapa chirwere chakasiyana nezvimwe imwe mishonga inogamuchirwa. "
Kuwedzera Rheumatoid Arthritis Zvinodhaka
Kubva muna 1998, apo Enbrel (etanercept) ndiyo yekutanga yebiologic inotengeswa neRheumatoid arthritis , biologic DMARDs (biologic zvirwere-kuchinja anti-rheumatic drugs) yakachinja maitiro ekurapa kune vanhu vanorwara nehosha. Nokutsvaga mahwendefa nemamwe masero anobatanidzwa mukufambira mberi kwerheumatoid arthritis, DMARD ye biologic uye DMARD itsva, inozivikanwa seJAK inhibitors, yakagadzirisa mararamiro evarwere vakawanda uye yakaita kuti kliniki iregere kune vamwe.
DMARD dzakawanda dzebiologic dzakagamuchirwa uye dzinotengeswa mumakore anotevera Enbrel achibvumira. Enbrel is TNF inhibitor . Mimwe mimwe mienzaniso yeTF inhibitors ikozvino inotengeswa ndeye Remicade (infliximab), Humira (adalimumab), Cimzia (certolizumab pegol), uye Simponi (golimumab). Pakave nemumwe JAK inhibitor akabvumirwa, muna 2012, anonzi Xeljanz (tofacitinib) .
Zvimwe DMARD zviri mukugadzirwa.
Biologic DMARDs yakakura mikoko yemapuroteti inofanira kuiswa kana kuiswa. JAK inhibitors madiki emapuroteni mapurotini ayo anowanikwa mumuromo (nemuromo).
Muna 2014, PhRMA yakataura kuti mishonga 92 yaiva mumatanho akasiyana ekuvandudza zvirwere zve musculoskeletal nemamiriro. Pakati pavo, 55 vakanga vachigadzirwa mukurapa rheumatoid arthritis. Ndiyo mishonga inosvika kuChikamu 3 mishonga yemakirini iyo inofanirwa kutarisirwa kwedu. Chikamu chechitatu chekuedza chinowanzobatanidza varwere vanopfuura 1 000 mukuedza kuratidza kuchengeteka uye kubudirira. Zvigumisiro zvinowanikwa kune FDA yekupedzisira kwemvumo yemishonga.
Chii chiri muPipeline?
Bharicitinib iJAK inhibitor mukufambisa kuburikidza naEli Lilly. Kana ikabvumirwa, Bharicitinib inenge iri yechipiri JAK inhibitor inobvumirwa. Bharicitinib inovhara JAK1 naJAK2. Kurapa neJAK inhibitors kunotarisirwa kune vanhu vakuru vane kuenzanisa kusvika kune simba rakaoma rheumatoid arthritis iyo yakave isina kukwana kugamuchira methotrexate kana kuti ndiani asingakwanisi kutsungirira methotrexate. Bharicitinib ine 65 muzana yekana yekubvumirwa, maererano nemumwe muongorori. Kana ikabvumirwa, inotarisirwa kukwikwidzana nemukwikwidzi wayo Xeljanz, zvichienderana nemutengo.
Sarilumab inonzi IL-6 inhibitor inokurudzirwa neSanofi / Regeneron. Pane zvikamu zvitanhatu zvese zvinoedzwa sarilumab. Mune imwe yezviedzo, sarilumab pamwe nemettretreate yakagadzirisa zvakanyanya kune varwere vane muongorori kusvika kune yakaoma rheumatoid arthritis kupfuura methotrexate chete, pasina kuonekwa kwakachengeteka kunetseka. Ichi chinodhaka, kana chichigamuchirwa, chichakwikwidzana nemumwe IL-6 inhibitor, Actemra (tocilizumab).
Secukinumab iI-17 inhibitor irikudziridzwa neNovartis Pharmaceuticals. Secukinumab inotarisirwa kune varwere vane rheumatoid arthritis vakange vasina kukodzera kugadziriswa neTAN inhibitors kana vakange vasingakwanisi kubvumira kurapwa ne TNF inhibitors.
Parizvino hapana imwe mishonga inopinza IL-17 mumugwagwa unovhiringidza .
Chimwe chinotarisirwa nemishonga, sirukumab yaJohnson & Johnson, yakarambidzwa kubvumidzwa neDFA munaSeptember 2017. Inotarisa nzira imwecheteyo na ACTEMRA (IL-6), zvichibatsira kuderedza kupisa. Zvisinei, FDA yakarondedzera "kusaenzana" muhuwandu hwevakafa vevanhu vanotora mishonga inopesana ne placebo muzviedzo, chigaro chakatanga kurondedzerwa mukurumbidzwa kwemazano eDAA .
Biosimilars
Kunewo maitiro mashomanana ekugadzirwa. Amgen iri kukura ABP 501, biosimilar kuna Humira. Boehringer Ingelheim Pharmaceuticals iri kukura BI 695500 seRituxan (rituximab) biosimilar. Coherus Biosciences iri kukura CHS-0214 seEnbrel biosimilar. Pane kunetseka pamusoro pekufananidzwa kwezvigadzirwa zvebiosimilar kune mushonga wepakutanga, pamwe chete neDAA yekubvumirwa kwenzira yezvinyorwa zvehupenyu.
> Sources:
> FDA Briefing Document. Arthritis Advisory Committee Meeting.
> PhRMA.2015 Purogiramu. Biopharmaceutical Research Industry.
> Regeneron uye Sanofi Parizvino Zvakawanikwa kubva Pivotal Phase 3 Chidzidzo cheSarilumab paAmerican College yeRheumatology Annual Meeting. November 8, 2015.
> Rheumatoid Arthritis (RA) Iropa Drug Pipeline. December 11, 2014.