Eyona >> Iindaba >> Dibana no-Ubrelvy, iyeza elitsha elamkelweyo le-FDA elinyanga i-migraine

Dibana no-Ubrelvy, iyeza elitsha elamkelweyo le-FDA elinyanga i-migraine

Iindaba

Phantse i-1 kumakhaya ama-4 ase-US, umntu unengxaki ye-migraine, ngokwe Isiseko soPhando lweMigraine . Kwaye uninzi lwabo bachaphazelekayo abakhange bafumane iyeza elisebenzayo. Ngoku, kukho entsha unyango lwe-migraine ukhetho kwihorizon. Kutshanje i-FDA ivume i-Ubrelvy (ubrogepant), iyeza elisebenza ngokukhawuleza ukunceda ukunciphisa ubude be-migraines.

Yintoni migraine?

I-Migraine ayisiyiyo nje intloko ebuhlungu. Ngapha koko, migraine ibalwa njenge sisifo sesithandathu esenza ukuba abantu bangakhubazeki ehlabathini. Ngaphandle kwentlungu ebukhali yentloko, ukuphazamiseka okubonakalayo, isicaphucaphu, ukugabha, isiyezi, ubuntununtunu obukhulu kwisandi, ukukhanya, ukubamba kunye nokujoja, kunye nokugungqa okanye ukuphazamiseka emaphethelweni okanye ubuso buhlala buhamba nemigraines.

Ezinxulumene : Nini ukuthetha nodokotela wakho malunga nemigqaliselo yemigraines

Ziqheleke kangakanani migraines?

I-12% yabemi-kubandakanya i-10% yabantwana-amava emigraines. Zichaphazela i-18% yabasetyhini baseMelika kunye ne-6% yamadoda. Lilonke, bangaphezulu kwesigidi se-4 sabantu abane-migraine yemihla ngemihla engapheliyo kunye namava ngaphezulu kweentsuku ze-15 zemigraine ngenyanga.

Unyango lwe-Migraine

Kukho amayeza amaninzi amayeza afumanekayo ukukhusela i-migraine, kunye nokunyanga iimpawu xa umntu eqala. Ukongeza, oogqirha ngamanye amaxesha bacebisa utshintsho kwindlela yokuphila (njengokunciphisa uxinzelelo okanye ukunciphisa ukukhanya kwezibane), khuthaza abaguli ukuba bathathe i-counter okanye i-NSAID yamandla amiselweyo (njenge ibuprofen ukulawula iintlungu, ukumisela i-antipsychotic, anti-depressants, antiepileptic drugs, beta blockers, kunye nokucebisa abaguli ukuba bafumane Inaliti yeBotox ukunciphisa amaza kunye neempawu zemigraine.

Ezinxulumene : Ngaba kufuneka uthathe i-Topamax kwimigraines yakho?

Yintoni i-Ubrelvy (ubrogepant)?

I-Ubrelvy (ubrogepant) lunyango lwamva nje lwe-migraines (kunye okanye ngaphandle kwe-aura). Lunyango lwenoveli, oko kukuthi, lixesha lokuqala olu luvunyiweyo ukuba lonyango lwe-migraine. Oko kunokuba ziindaba eziguqula ubomi kwizigulana ezingakhange zikufumane ukukhululeka kwiziyobisi ezikhoyo.

Amachiza avunyiweyo e-FDA aqinisekisiwe ngokwezonyango ukuba anciphise ubude be-migraine episodes, kunye nokunciphisa iintlungu kunye neempawu ezinxulumene nazo. Isebenza ngokuthintela iziphumo ze-calcitonin peptide enxulumene nemfuza (CGRP) receptor. I-CGRP ibonakalisiwe ukuba iyinto enye yangaphakathi ebangela kwaye igcine imigraines. Kwaye nangona zikho ezinye iziyobisi -Iinaliti ngegama lika UAimovig , Ubungqongqo , kunye Uhambo -Oku kuthintela i-migraines ngokuthintela i-CGRP, i-Ubrelvy ime yodwa kuba liyeza elisebenza ngomlomo elisebenza ukunyanga imigraines xa sele zisenzeka. Kuza kunye nokukhethwa kweedosi ezimbini (i-50 kunye ne-100 mg yeepilisi) ukubonelela ngokuguqukayo kwiimfuno zezigulana kunye nokwenza ngcono ukusebenza kwabemi abaninzi.

I-Ubrelvy yadlula kuvavanyo lweklinikhi kunye novavanyo, olukhokelele ekuvunyweni kwayo kokugqibela kulawulo. Ngokuka-FDA, ukusebenza kweyeza kubonisiwe kwizilingo ezilawulwa ngokungekho mthethweni, ezibini ezingaboniyo, ezilawulwa yi-placebo. Ngexesha lezifundo, izigulana zabantu abadala ze-1,439 ezinembali ye-migraine (kunye nangaphandle kwe-aura) ifumene iidosi ezivunyiweyo ze-Ubrelvy ukunyanga i-migraine eqhubekayo.

Kwizifundo zombini, malunga ne-19% yezigulana zichaze ukungaziva zintlungu kwiiyure ezimbini emva konyango (kuchazwa njengokunciphisa ubukrakra bentloko ukusuka kwintlungu ephakathi okanye ebuhlungu ukuya kwintlungu) kwaye i-38.6% ichaze uvakalelo olupheleleyo kwisibonakaliso sabo esongezelelekileyo se-migraine (isicaphucaphu , ubuntununtunu bokukhanya, okanye uvakalelo lwesandi) kwiiyure ezimbini emva konyango. Ezi pesenti ziphezulu kakhulu phakathi kwezigulana ezifumana i-Ubrelvy (nakweyiphi na idosi) xa kuthelekiswa nezo zifumene i-placebo.

Iziphumo ebezingalindelekanga eziqhelekileyo kwi-Ubrelvy sisicaphucaphu kunye nokudinwa (ukudinwa).

Njenge-gepant yokuqala yomlomo, i-Ubrelvy ibonelela ngohlobo olwahlukileyo kunye nolwahlukileyo lokhetho olunamandla kubantu abaphila nentlungu ebuthathaka kunye nezinye iimpawu ze-migraine, uDavid Nicholson, usekela-mongameli olawulayo kunye negosa eliyintloko le-R & D lenkampani yelayisensi yase-Ubrelvy, u-Allergan, utshilo. upapasho ndaba zekhampani . Ukulawulwa kwayo ngomlomo ngamanqanaba amabini edosi kuvumela ukuba unyango lube bhetyebhetye kunye nokukhululeka xa kuhlaselwe migraine. Njengoko siqhubeka ukuqhuba izinto ezintsha kunyango lwe-migraine, siyazingca ngokunika izigulana enye indlela, kwaye siqinisekile ukuba iyakwenza umahluko kwabo bafuna uncedo. E-Allergan, sikholelwa ukuba izigulana ze-migraine zifanelwe ukufikelela kuwo onke amayeza amatsha kwesi sifo sidodobalisayo.