SYK inhibitori Tavalisse (fatantinib) 3-bosqich Yaponiyada o'rganish muvaffaqiyatli bo'ldi!

Rigel Pharmaceuticals yaqinda uning hamkori Kissei Pharmaceuticals Yaponiyada o'tkazilgan 3-bosqich klinik tadqiqotining ijobiy natijalarini e'lon qildi. Tadqiqotda surunkali immun trombotsitopeniya (ITP) bo'lgan katta yoshli bemorlarni davolash uchun Tavalisse (fostamatinib disodium hexahydrate) baholanmoqda.

The results of this phase 3 clinical study (n=34) showed that the proportion of patients in the Tavalisse treatment group who achieved a stable platelet response was significantly higher than that in the placebo group. A stable platelet response is defined as: in the last 6 planned visits during the 14-24 week of treatment, at least 4 blood platelet counts are ≥50,000 platelets/μL. In this study, the safety of Tavalisse was consistent with other clinical trials, and no new or abnormal safety issues were found.

2018 yil oktyabr oyida Rigel va Kissei Yaponiya, Xitoy va Janubiy Koreyada fostamatinibning barcha mavjud va potentsial ko'rsatkichlarini ishlab chiqish uchun eksklyuziv litsenziya va yetkazib berish shartnomasini imzoladilar. Qo'shma Shtatlarda fostamatinib 2018 yil aprel oyida tasdiqlangan va oldingi davolanishlarga etarli darajada javob bermagan surunkali ITP bilan kasallangan katta yoshli bemorlarni davolash uchun Tavalisse savdo nomi ostida sotilgan.

Tavalisse faol farmatsevtik moddalar

Immun trombotsitopeniya (ITP) kamdan-kam uchraydigan va jiddiy otoimmün kasallik bo'lib, u immunitet tizimining o'z trombotsitlariga hujum qilishi va yo'q qilishi, natijada qonda trombotsitlar sonining pastligi (trombotsitopeniya), oson qon ketishi va bemorlarga zararli ta'sir ko'rsatishi bilan tavsiflanadi. salbiy ta'sir ko'rsatadi. Surunkali ITP bilan og'rigan bemorlarda og'ir qon ketish xavfi ortadi, bu jiddiy tibbiy asoratlar va hatto o'limga olib kelishi mumkin. ITP uchun hozirgi davolash usullariga steroidlar, gematogenez promotorlari (TPO retseptorlari agonistlari) va splenektomiya kiradi. Biroq, barcha bemorlarni mavjud davolash usullari bilan etarli darajada davolash mumkin emas. Shuning uchun ITP bilan og'rigan bemorlar hali ham ko'proq davolash usullariga muhtoj.

Tavalisse og'iz orqali taloq tirozin kinaz (SYK) inhibitori bo'lib, trombotsitlarni yo'q qilishning oldini olish orqali kasallikning asosiy otoimmün sabablarini yo'q qiladi va surunkali ITP bo'lgan kattalar bemorlarini davolashning muhim yangi variantini ta'minlaydi.

Dr. Wolfgang Dummer, Executive Vice President and Chief Medical Officer of Rigel, said: "These Phase 3 research results add a lot of evidence to prove that fostamatinib may provide meaningful benefits for patients with ITP. Fostamatinib has a unique mechanism of action that addresses ITP by preventing platelet destruction. Potential autoimmune causes. We are also continuing to evaluate the potential of fostamatinib to treat warm antibody autoimmune hemolytic anemia (wAIHA), another rare blood disease in which the immune system destroys blood cells."