FDA ta Amurka ta Amince da Sabon Magani ga Myasthenia Gravis

Myasthenia gravis wani cuta ne na yau da kullun na autoimmune, cututtukan neuromuscular wanda ke haifar da rauni a cikin tsokoki na kwarangwal (wanda kuma ake kira tsokoki na son rai) wanda ke tsanantawa bayan lokutan aiki kuma yana inganta bayan lokutan hutu. Myasthenia gravis yana shafar tsokoki na son rai, musamman waɗanda ke da alhakin sarrafa idanu, fuska, baki, makogwaro, da gaɓoɓi. A cikin myasthenia gravis, tsarin garkuwar jiki yana samar da kwayoyin cutar AChR wanda ke tsoma baki tare da sadarwa tsakanin jijiyoyi da tsokoki, wanda ke haifar da rauni. Mummunan hare-haren rauni na iya haifar da matsalolin numfashi da haɗiye waɗanda ke da haɗari ga rayuwa.

Billy Dunn, MD, darektan Ofishin Neuroscience a Cibiyar Nazarin Magunguna da Magunguna ta FDA ta ce "Akwai manyan buƙatun likita waɗanda ba su cika ba ga mutanen da ke fama da myasthenia gravis, kamar yadda yake tare da sauran cututtukan da ba kasafai ba. "Yin amincewar yau wani muhimmin mataki ne na samar da wani zaɓi na magani ga marasa lafiya tare da jaddada ƙudirin hukumar na taimakawa wajen samar da sabbin hanyoyin magani ga mutanen da ke fama da cututtukan da ba kasafai ba."

Vyvgart shine farkon amincewar sabon nau'in magani. Guntun antibody ne wanda ke ɗaure ga mai karɓar Fc na jariri (FcRn), yana hana FcRn sake yin amfani da immunoglobulin G (IgG) cikin jini. Magungunan yana haifar da raguwa a cikin matakan IgG gabaɗaya, gami da ƙarancin rigakafi na AChR waɗanda ke cikin myasthenia gravis.

An kimanta aminci da ingancin Vyvgart a cikin binciken asibiti na makonni 26 na marasa lafiya 167 tare da myasthenia gravis waɗanda aka bazu don karɓar ko dai Vyvgart ko placebo. Nazarin ya nuna cewa mafi yawan marasa lafiya tare da myasthenia gravis tare da kwayoyin rigakafi sun amsa magani a lokacin zagaye na farko na Vyvgart (68%) idan aka kwatanta da wadanda suka karbi placebo (30%) akan ma'auni wanda ke kimanta tasirin myasthenia gravis akan aikin yau da kullum. Ƙarin marasa lafiya da ke karɓar Vyvgart kuma sun nuna amsa akan ma'auni na raunin tsoka idan aka kwatanta da placebo.

Mafi yawan illolin da ke tattare da amfani da Vyvgart sun haɗa da cututtuka na numfashi, ciwon kai, da cututtuka na urinary fili. Kamar yadda Vyvgart ke haifar da raguwa a matakan IgG, haɗarin cututtuka na iya karuwa. Halayen rashin jin daɗi kamar kumburin fatar ido, ƙarancin numfashi, da kurji sun faru. Idan halayen rashin hankali ya faru, dakatar da jiko kuma kafa maganin da ya dace. Marasa lafiya da ke amfani da Vyvgart yakamata su saka idanu akan alamu da alamun cututtuka yayin jiyya. Ma'aikatan kiwon lafiya ya kamata su ba da magani mai dacewa kuma suyi la'akari da jinkirta gudanarwa na Vyvgart ga marasa lafiya da kamuwa da cuta har sai an magance cutar.

FDA ta ba da wannan aikace-aikacen Fast Track da sunayen Magungunan Marayu. FDA ta ba da izinin Vyvgart zuwa argenx BV.