Magungunan miyagun ƙwayoyi sun ƙunshi rukuni na kwayoyi da suke cikin ci gaba a kowane lokaci da wasu kamfanoni masu magunguna suke. Magunguna a cikin bututun mai shiga cikin manyan hanyoyi 4: ganowa, jarabawa, gwaji, da kuma tallace-tallace (wanda ya faru bayan yarda).
Akwai kimanin kwayoyi 5,000 a ci gaba a yau a Amurka kadai don yanayi daban-daban.
Masu bincike sunyi ƙoƙarin samar da kwayoyi ga marasa lafiya wadanda basu da bukatun. A cewar PhRMA (Masana Kimiyya da Ma'aikata na Amurka), "A shekara ta 2014, Cibiyar Abinci da Kwayoyi ta Amurka (FDA) ta amince da sababbin magungunan 51 a cikin bangarori daban-daban na cututtuka. Cibiyoyin Drug sun samu arba'in daga cikin wadanda aka tabbatar da su. Binciken da Bincike (CDER) a FDA, mafi girma tun daga 1996. Daga cikin CDER approvals, kashi 41 cikin dari an gano su ne a matsayin magunguna na farko, ma'anar suna amfani da mahimman tsari don magance yanayin kiwon lafiya wanda ya bambanta da kowane wasu maganin da aka yarda. "
Samar da Rheumatoid Arthritis Drugs
Tun 1998, a lokacin da Enbrel ( kwayar halitta ) ta kasance da farko da aka sayar da kwayar cutar ta hanyar maganin cututtuka , maganin kwayoyin halitta (maganin cututtuka na maganin cututtuka na zamani) ya canza wuri mai jiyya don mutanen dake fama da cutar. Ta hanyar ƙaddamar da ƙwayoyin kwayoyin halitta da kuma kwayoyin da ke cikin ci gaban maganin arthritis, DMARDs da kuma sababbin DMARDs, wanda aka sani da masu hana JAK, sun inganta maganin da aka yi wa marasa lafiya da yawa kuma sun yiwu wasu sun sami gafara .
Yawancin DMARDs masu nazarin halittu sun yarda da kasuwa a cikin shekarun da Enbrel ya yarda. Enbrel mai amfani ne a cikin TNF . Sauran misalai na masu tayar da hankulan TNF a halin yanzu ana sayarwa su ne Remicade (infliximab), Humira (adalimumab), Cimzia (certolizumab pegol), da Simponi (golimumab). An sami wanda aka yarda da JAK wanda ya yarda, a shekarar 2012, mai suna Xeljanz (tofacitinib) .
Ƙarin DMARDs suna ci gaba.
DMARDs masu ilimin halitta sune sunadaran sunadarai masu yawa waɗanda dole ne a yi musu injected ko kuma bazasu. Masu hana JAK sune kananan sunadaran kwayoyin da ake gudanarwa a baki (ta baki).
A shekara ta 2014, PhRMA ya ruwaito cewa kwayoyi 92 sun kasance a cikin matakai daban-daban na ci gaba don cututtuka da ƙwayoyin cuta. Daga cikin wadanda, 55 an ci gaba da bunkasa don maganin cututtuka na rheumatoid. Yana da kwayoyi da zasu kai gwajin gwaji na 3 na gwaji na asibiti wanda ya fi cancanci kulawa. Sakamakon gwaji na 3 yana kunshe da fiye da 1,000 marasa lafiya a ƙoƙarin tabbatar da aminci da tasiri. An gabatar da sakamakon zuwa FDA don amincewa da miyagun kwayoyi.
Menene a cikin Pipeline?
Baricitinib ne mai hana JAK a cikin ci gaba ta hanyar Eli Lilly. Idan an yarda, Baricitinib zai zama mai yarda da JAK na biyu. Baricitinib tubalan JAK1 da JAK2. Yin jiyya tare da masu hana JAK an yi nufi ne ga tsofaffi da masu cike da ƙwayar maganin ƙwaƙwalwar ƙwayar cuta wanda ke da matsananciyar matsananciyar rauni waɗanda suka yi rashin dacewar amsa ga hanya ko wanda ba zai iya jurewa hanya ba. Baricitinib na da kashi 65 bisa dari na yarda, kamar yadda wani mai nazari ya ce. Idan an yarda, ana sa ran zama mai gasa a kan mai fasaha Xeljanz, dangane da farashin.
Sarilumab shi ne mai gabatar da IL-6 wanda Sanofi / Regeneron ya ci gaba. Akwai lokuta uku na gwaji don sarilumab. A cikin ɗayan gwaji, sarilumab da methotrexate sun fi dacewa ga marasa lafiya da matsananciyar cututtuka na rheumatoid fiye da yadda kawai yake, ba tare da damuwarsu ba. Wannan miyagun ƙwayoyi, idan an yarda, zai yi gasa tare da wani mai hana IL-6, Actemra (tocilizumab).
Secukinumab ne mai maganin IL-17 wanda aka gina ta Novartis Pharmaceuticals. Secukinumab yana nufin marasa lafiya da cututtukan arthritis wanda ke da rashin dacewar amsawa tare da masu hanawa TNF ko waɗanda basu iya jurewa jiyya tare da masu hanawa TNF ba.
A halin yanzu babu wani maganin miyagun ƙwayoyi da ke kai hari ga IL-17 a cikin hanyar ƙwayar cuta .
Wani mawuyacin magunguna, Johnson & Johnson's sirukumab, sun ki amincewa da FDA a cikin watan Satumbar 2017. Tana da hanyar hanya daya kamar ACTEMRA (IL-6), yana taimakawa wajen rage ƙonewa. Duk da haka, FDA ta nuna "rashin daidaituwa" a yawan mutuwar mutanen da ke shan maganin miyagun ƙwayoyi a matsayin wuribo a gwaji, matsayi wanda aka tsara a cikin shawarar shawarwarin kwamitin FDA .
Biosimilars
Akwai wasu 'yan biosimilars a ci gaba. Amgen yana tasowa ABP 501, mai zaman kansa kamar Humira. Boehringer Ingelheim Pharmaceuticals yana tasowa BI 695500 a matsayin Rituxan (rituximab). Coherus Biosciences na cigaba da bunkasa CHS-0214 a matsayin mai launi na Enbrel. Akwai damuwa game da daidaitaccen kayan samfurori ga asibiti na asali, da kuma tsarin FDA na biosimilars.
> Sources:
> Takardar Briefing FDA. Arthritis Advisory Committee Meet.
> PhRMA.2015 Profile. Biopharmaceutical Research Industry.
> Sakamakon Sanofi da Sanofi daga Mataki na Pivotal 3 Nazarin Sarilumab a Cibiyar Kwalejin Rheumatology ta Amirka. Nuwamba 8, 2015.
> Ritumatoid Arthritis (RA) Sabon Kwayar Drug. Disamba 11, 2014.