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I-FDA ivuma i-Gilenya generic

I-FDA ivuma i-Gilenya genericIindaba

Phantse ishumi leminyaka, abantu abanamatyala abuyayo e-multiple sclerosis (MS) babenokhetho olunye kunyango: Gilenya . Yayikuphela konyango olwamkelweyo yi-FDA kubantu abadala kunye nabantwana abaneminyaka eli-10 nangaphezulu, kwiveki ephelileyo.





NgoDisemba 5, i-US Food and Drug Administration (FDA) kwaziswa imvume ye-generic Gilenya, fingolimod, kwi-HEC Pharm Co Limited, kwi-Biocon Limited, nakwi-Sun Pharmaceutical Industries Limited.



Yintoni iGilenya?

Yenziwe yiNovartis Pharmaceuticals Corporation, iGilenya yaqala yamkelwa yi-FDA ngo-2010. Yayilunyango lokuqala lomlomo olwenzelwe ukunciphisa ukubuyela umva kunye nokunciphisa ukuqhubela phambili kwezifo. Kwi Ngo-2018 , I-FDA yandise ukwamkelwa kwayo kwesiyobisi ukubandakanya izigulana zabantwana.

Inkqubo ye- Okwangoku kucetyiswa idosi I-Gilenya yabantu abadala kunye nabantwana abaneminyaka eli-10 okanye ngaphezulu kwaye ubunzima obungama-40 kg yi-0.5 mg capsule ngemini. Abantwana abaneminyaka eli-10 ubuncinci kodwa benobunzima obungama-40 kg okanye ngaphantsi kufuneka bathathe i-capsule enye ye-0.25 mg ngosuku.

Yintoni iMS?

I-MS sisifo sokudumba komzimba, esithetha ukuba iiseli zomzimba zomzimba zihlasela isimbo esinamafutha semisonto yentsimbi, ukuphazamisa iimpembelelo zentliziyo kunye nokubangela iimpawu ezinje ngokubuthathaka kwezihlunu, ukudinwa, ukuba ndindisholo okanye ukurhawuzelela, ukuphazamiseka kwemisipha, ukuhamba nzima, utshintsho lombono, kunye nesinyi okanye isilonda ukungasebenzi. Uninzi lwabantu lufumana imijikelezo yokubuyela umva kulandelwe kukuxolelwa. Ixesha elingaphezulu, kunzima ukufezekisa uxolelo olupheleleyo emva kokuqhambuka, kwaye isifo siyaqhubeka.



Gilenya lolona nyango lusetyenziswa kakhulu kwezi meko. Kucingelwa ukuba kusebenza ngokunciphisa iiseli zomzimba ezijikeleza emzimbeni, ngaloo ndlela kuncitshiswa uhlaselo lweeseli zemithambo-luvo ezibangela iimpawu.

Ixabisa malini iGilenya?

Ngokuyinxenye ngenxa yokukhuselwa kwelungelo elilodwa lomenzi, indleko zeGilenya zahlala ziphezulu- ixabiso eliphakathi $ 8,211 yokubonelela ngeentsuku ezingama-30 zeephilisi ze-0.5mg.Nangona, I-Novartis Uninzi lwezicwangciso zeinshurensi yezempilo zigubungela amayeza, kubandakanya iipesenti ezingama-99 zabantu abaneinshurensi yorhwebo kunye nama-96% abantu abaneMedicaid okanye iMedicare. INovartis ikwabonelela ngenkqubo yokuhlawula imali kunye ukunceda ukuhlawula ichiza.

Olu lwamkelo linyathelo lokuqala elisa kukhuphiswano lohlobo oluthile, olunokuhlisa iindleko zolu nyango.



Ukujongana nemiceli mngeni enxulumene nokuphuhlisa i-generic kunye nokukhuthaza ukhuphiswano ngakumbi lwenxalenye yento ebalulekileyo kwi-FDA's isiCwangciso soKhuphiswano lweziyobisi kunye neenzame ze-arhente zokunceda ukwandisa ukufikelela kwesigulana kumayeza afikelelekayo, i-FDA ingxelo utshilo.

Iya kufumaneka nini i-generic Gilenya?

Akukabhengezwa okwangoku xa abenzi bamayeza abathathu abafumene imvume baya kuqala ukuthengisa i-fingolimod (i-genilenia generic) e-United States. Akukho lwakhiwo lwamaxabiso lufumanekayo okwangoku, nokuba.