Ummangali iBristol Myers Squibb Company (BMS) ufake icala ngokumelene nommangalelwa i-Xspray Pharma AB eNew Jersey County ngoLwesithathu. Icala lokwephulwa kwelungelo lobunikazi lihlose ukuvimbela Abamangalelwa ekwenzeni nasekuthengiseni izinhlobo ezijwayelekile zesidakamizwa sikaMmangali iSprycel.
I-Sprycel ihloselwe ukwelapha abantu abadala nezingane ezitholakale zinezinhlobo ezahlukene ze-leukemia. Abamangali baphethe amalungelo obunikazi amabili, ilungelo lobunikazi lika-'725 kanye nelungelo lobunikazi lika-'103 (ilungelo lobunikazi elisesikhwameni), elinesihloko esithi “Izindlela zokulungiselela ama-carboxamides angu-2-aminothiazole-5-aromatic njenge-kinase inhibitors.” La malungelo obunikazi akhishwe ngo-2009 nango-2014 ngokulandelana. Ngaphezu kwelungelo lobunikazi okukhulunywa ngalo, abamangali banesicelo esisha semithi (NDA) somuthi ophuzwayo.
Ngokusho kwesikhalazo, i-Xspray ithumele isivumelwano sokungadaluli ku-FDA lapho befuna khona imvume yokukhiqiza nokumaketha uhlobo olujwayelekile lwe-Sprycel. Phakathi kwezinye izinto, i-Xspray ixhumane nabamangali futhi yabatshela ukuthi izimangalo zelungelo lobunikazi eziphikiswana ngazo azivumelekile noma aziphulwanga yimikhiqizo yabamangalelwa yesikhathi esizayo.
Incwadi ye-Xspray eya kubamangali yabanika ukufinyelela okuyimfihlo ezingxenyeni ezithile ze-Xspray NDA, kodwa ayizange inike abamangali ukufinyelela ifayela eliyinhloko lezidakamizwa. Abamangali abanakho ukufinyelela kumafayela amakhulu ezidakamizwa, okuvimbela "ikhono labo lokubukeza ulwazi oluhlobene nokuhlaziywa kwabo kokwephulwa komthetho," kusho isikhalazo.
Isikhalazo sithi i-Xspray yephula okungenani isimangalo esisodwa selungelo ngalinye lobunikazi okukhulunywa ngalo. Ngaphezu kwalokho, Abamangali bachaza ukuthi Abamangalelwa bamemezele inhloso yabo yokukhiqiza nokumaketha imikhiqizo yabo ye-NDA ngokushesha ngemuva kokuvunyelwa yi-FDA, okuyinto Abamangali abathi izokwephula amalungelo obunikazi okukhulunywe ngawo ngenhla.
I-BMS iphikise ngokuthi uma abamangalelwa bengavinjelwanga ekuqhubekeni nokwephula amalungelo obunikazi okukhulunywa ngawo, bazobhekana “nomonakalo omkhulu futhi ongenakulungiswa”. Isikhalazo sibala amacala amabili okwephulwa kwamalungelo obunikazi. Abamangali bafuna isinqumo esihle ngecala ngalinye, umyalelo wokuvimbela ukwephulwa kwamalungelo obunikazi okuqhubekayo, umyalelo oqinisekisa ukuthi imikhiqizo ye-NDA yabamangalelwa ngeke ikhiqizwe ngaphambi kokuba ilungelo lobunikazi okukhulunywa ngalo liphelelwe yisikhathi, impumuzo yemali uma abamangalelwa bekhangisa imikhiqizo yabo ye-NDA, nokuningi.
Isikhathi sokuthunyelwe: Ephreli-12-2023