I-Dova Pharmaceuticals ithe i-US Food and Drug Administration (FDA) igunyaze amaphilisi amasha esidakamizwa se-AkaRx i-Doptelet (avatrombopag) yokwelapha isibalo esiphansi seplatelet (thrombocytopenia) kubantu abadala abanesifo sesibindi esingamahlalakhona (CLD) abazohlinzwa umdlavuza noma izinyo. Kuhle ukusho ukuthi lesi umuthi wesithathu omusha ogunyazwe i-FDA phakathi nesonto kanye nomuthi wokuqala ogunyazwe le njongo njengamanje.
Ama-platelet amangqamuzana angenambala akhiqizwa emnkantsheni asiza ukwakha amahlule egazi emithanjeni yegazi futhi avimbele ukopha. I-Cancer chemotherapy ngokuvamile ibangela i-thrombocytopenia.
I-Doptelet (avatrombopag) isizukulwane sesibili, i-receptor agonist eyamukelwa kanye ngomlomo nsuku zonke (TPO). I-Doptelet ingalingisa umphumela we-TPO, ingumlawuli oyinhloko wokukhiqizwa kweplatelet ejwayelekile. Lesi sidakamizwa sithole iziqu zokubuyekeza kuqala ukwelapha i-thrombocytopenia kubantu abadala abane-CLD abazohlinzwa.
Ukuphepha nokusebenza kukaDoptelet kuqinisekisiwe ezivivinyweni ezimbili (i-ADAPT-1 ne-ADAPT-2). Lezi zifundo zifaka phakathi ingqikithi yeziguli ezingama-435 ezinezifo ezingamahlalakhona zesibindi kanye ne-thrombocytopenia enamandla, ezohlinzwa ngokuvamisile okudinga ukumpontshelwa iplatelet. Lezi zivivinyo zihlolisise umphumela we-doptelet yomlomo emazingeni womthamo amabili ngokuqhathaniswa ne-placebo yezinsuku eziyi-5 zokwelashwa. Imiphumela ikhombise ukuthi uma kuqhathaniswa neqembu le-placebo, iphesenti eliphakeme leziguli eziseqenjini lamadosi amabili le-Doptelet group likhuphukile ukubalwa kweplatelet futhi alidingi ukuthola ukumpontshelwa kweplatelet noma ukwelashwa ngelanga lokuhlinzwa nangaphakathi kwezinsuku eziyi-7 ngemuva kokwelashwa . Imiphumela emibi kakhulu ye-Doptelet umkhuhlane, isisu (isisu), isicanucanu, ikhanda, ukukhathala nokuvuvukala kwezandla nezinyawo (i-edema).
"Iziguli ezinamanani aphansi eplatelet nezifo ezingapheli zesibindi ezidinga ukuhlinzwa zisengozini enkulu yokopha," kusho uDkt Richard Pazdur, umqondisi weCentre for Excellence in Oncology kanye nomqondisi obambile we-Office of Hematology and Oncology Products e-FDA Center Ukuhlolwa Kwezidakamizwa Nocwaningo. Khulisa isibalo seplatelet. Lesi sidakamizwa singanciphisa noma siqede isidingo sokumpontshelwa kweplatelet, (ukufakwa kweplatelet) kungakhuphula ubungozi bokutheleleka nokunye ukusabela okungahambi kahle.
