I-US FDA Igunyaza Ukwelashwa Okusha kwe-Myasthenia Gravis

I-Myasthenia gravis yisifo esingelapheki sokuzivikela komzimba, isifo se-neuromuscular esibangela ubuthakathaka emisipha yamathambo (ebizwa nangokuthi imisipha yokuzithandela) eba yimbi ngemva kwezikhathi zomsebenzi futhi iba ngcono ngemva kwezikhathi zokuphumula. I-Myasthenia gravis ithinta imisipha yokuzithandela, ikakhulukazi lezo ezinomthwalo wemfanelo wokulawula amehlo, ubuso, umlomo, umphimbo nezitho. Ku-myasthenia gravis, amasosha omzimba akhiqiza amasosha omzimba e-AChR aphazamisa ukuxhumana phakathi kwemizwa nemisipha, okuholela ebuthakathakeni. Ukuhlaselwa okunzima kobuthakathaka kungabangela ukuphefumula nokugwinya izinkinga ezingase zibe yingozi empilweni.

“Kunezidingo ezibalulekile zezokwelapha ezingakafinyelelwa kubantu abaphila ne-myasthenia gravis, njengezinye izifo eziningi ezingavamile,” kusho uBilly Dunn, MD, umqondisi weHhovisi Lesayensi Yezinzwa eSikhungweni Sokuhlola Nokucwaninga Sezidakamizwa se-FDA. “Ukugunyazwa kwanamuhla kuyisinyathelo esibalulekile ekunikezeni iziguli indlela entsha yokwelapha futhi kugcizelela ukuzibophezela kwale nhlangano ekusizeni ukuthi izindlela ezintsha zokwelapha zitholakale kubantu abaphila nezifo ezingandile.”

I-Vyvgart iyimvume yokuqala yekilasi elisha lomuthi. Kuwucezu lwe-antibody olubophezela ku-neonatal Fc receptor (FcRn), ukuvimbela i-FcRn ekubuyiseleni i-immunoglobulin G (IgG) egazini. Umuthi udala ukwehla kumazinga e-IgG ewonke, okuhlanganisa amasosha omzimba e-AChR akhona ku-myasthenia gravis.

Ukuphepha nokusebenza ngempumelelo kwe-Vyvgart kwahlaziywa ocwaningweni lomtholampilo lwamasonto angama-26 lweziguli eziyi-167 ezine-myasthenia gravis ezahlelwa ngokungahleliwe ukuze zithole i-Vyvgart noma i-placebo. Ucwaningo lubonise ukuthi iziguli eziningi ezine-myasthenia gravis ezinama-antibodies zasabela ekwelashweni phakathi nomjikelezo wokuqala we-Vyvgart (68%) uma kuqhathaniswa nalabo abathola i-placebo (30%) esilinganisweni esihlola umthelela we-myasthenia gravis emsebenzini wansuku zonke. Iziguli ezengeziwe ezithola i-Vyvgart nazo zibonise ukusabela ngesilinganiso sobuthakathaka bemisipha uma kuqhathaniswa ne-placebo.

Imiphumela evame kakhulu ehambisana nokusetshenziswa kwe-Vyvgart ihlanganisa izifo zepheshana lokuphefumula, ikhanda elibuhlungu, kanye nezifo ze-urinary tract. Njengoba i-Vyvgart ibangela ukwehla kwamazinga e-IgG, ingozi yokutheleleka ingase ikhule. Ukusabela kwe-hypersensitivity njengokuvuvukala kwejwabu leso, ukuphelelwa umoya, nokuqubuka. Uma ukusabela kwe-hypersensitivity kwenzeka, yeka ukumnika bese usungula ukwelashwa okufanele. Iziguli ezisebenzisa i-Vyvgart kufanele ziqaphe izimpawu nezimpawu zokutheleleka ngesikhathi sokwelashwa. Ochwepheshe bezokunakekelwa kwempilo kufanele banikeze ukwelashwa okufanele futhi bacabangele ukubambezela ukuphathwa kwe-Vyvgart ezigulini ezinokutheleleka okusebenzayo kuze kube yilapho ukutheleleka sekuxazululiwe.

I-FDA inikeze lolu hlelo lokusebenza amagama e-Fast Track kanye ne-Orphan Drug. I-FDA inikeze imvume ye-Vyvgart ku-argenx BV.