\u0110\u00e2y l\u00e0 d\u1ea1ng b\u00e0o ch\u1ebf m\u1edbi c\u1ee7a glibenclamide, \u0111\u01b0\u1ee3c ph\u00e1t tri\u1ec3n chuy\u00ean bi\u1ec7t \u0111\u1ec3 s\u1eed d\u1ee5ng cho tr\u1ebb s\u01a1 sinh, tr\u1ebb b\u00fa m\u1eb9 v\u00e0 tr\u1ebb nh\u1ecf.
\n\u1ee6y ban v\u1ec1 Ch\u1ebf ph\u1ea9m y t\u1ebf s\u1eed d\u1ee5ng tr\u00ean ng\u01b0\u1eddi c\u1ee7a C\u01a1 quan Qu\u1ea3n l\u00ed D\u01b0\u1ee3c ch\u00e2u \u00c2u (EMA-CHMP) m\u1edbi \u0111\u00e2y \u0111\u00e3 t\u01b0 v\u1ea5n c\u1ea5p ph\u00e9p cho l\u01b0u h\u00e0nh Amglidia (glibenclamide) trong Li\u00ean minh ch\u00e2u \u00c2u (EU), \u0111\u00e2y l\u00e0 m\u1ed9t thu\u1ed1c \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh cho \u0111i\u1ec1u tr\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng s\u01a1 sinh, d\u00f9ng \u0111\u01b0\u1ee3c cho tr\u1ebb s\u01a1 sinh, tr\u1ebb b\u00fa m\u1eb9 v\u00e0 tr\u1ebb nh\u1ecf.<\/p>\n
\u0110\u00e1i th\u00e1o \u0111\u01b0\u1eddng s\u01a1 sinh l\u00e0 th\u1ec3 \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng c\u1ef1c k\u00ec hi\u1ebfm g\u1eb7p \u0111\u01b0\u1ee3c ch\u1ea9n \u0111o\u00e1n trong v\u00f2ng 6 th\u00e1ng \u0111\u1ea7u \u0111\u1eddi. B\u1ec7nh g\u00e2y \u0111e d\u1ecda t\u00ednh m\u1ea1ng v\u00e0 suy ki\u1ec7t b\u1edfi c\u00e1c tri\u1ec7u ch\u1ee9ng do \u0111\u01b0\u1eddng huy\u1ebft t\u0103ng cao v\u00e0 nguy c\u01a1 nhi\u1ec5m toan ceton, \u0111\u00f3 l\u00e0 t\u00ecnh tr\u1ea1ng r\u1ea5t n\u1eb7ng c\u00f3 th\u1ec3 g\u1eb7p \u1edf ng\u01b0\u1eddi \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng n\u1ebfu c\u01a1 th\u1ec3 b\u1eaft \u0111\u1ea7u s\u1eed d\u1ee5ng h\u1ebft insulin v\u00e0 sinh ra th\u1ec3 ceton trong c\u01a1 th\u1ec3. Nhi\u1ec1u \u0111\u1ed9t bi\u1ebfn gene kh\u00e1c nhau \u0111\u00e3 \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh l\u00e0 nguy\u00ean nh\u00e2n g\u00e2y ra th\u1ec3 \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng n\u00e0y.<\/p>\n
Amglidia l\u00e0 d\u1ea1ng b\u00e0o ch\u1ebf \u0111\u01b0\u1eddng u\u1ed1ng m\u1edbi c\u1ee7a glibenclamide, ho\u1ea1t ch\u1ea5t \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p cho \u0111i\u1ec1u tr\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng type 2, \u0111\u01b0\u1ee3c ph\u00e1t tri\u1ec3n chuy\u00ean bi\u1ec7t \u0111\u1ec3 s\u1eed d\u1ee5ng cho tr\u1ebb s\u01a1 sinh, tr\u1ebb b\u00fa m\u1eb9 v\u00e0 tr\u1ebb nh\u1ecf m\u1eafc \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng s\u01a1 sinh.<\/p>\n
Amglidia t\u00e1c d\u1ee5ng l\u00ean t\u1ebf b\u00e0o s\u1ea3n xu\u1ea5t insulin \u1edf t\u1ee5y b\u1eb1ng c\u00e1ch g\u1eafn v\u1edbi k\u00eanh kali nh\u1ea1y c\u1ea3m ATP (KATP), k\u00eanh n\u00e0y ki\u1ec3m so\u00e1t s\u1ef1 gi\u1ea3i ph\u00f3ng insulin. \u1ede nhi\u1ec1u em b\u00e9 m\u1eafc \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng s\u01a1 sinh, c\u00e1c t\u1ebf b\u00e0o tuy\u1ebfn t\u1ee5y s\u1ea3n xu\u1ea5t insulin nh\u01b0ng kh\u00f4ng gi\u1ea3i ph\u00f3ng \u0111\u01b0\u1ee3c v\u00e0o m\u00e1u do \u0111\u1ed9t bi\u1ebfn gen d\u1eabn t\u1edbi r\u1ed1i lo\u1ea1n ch\u1ee9c n\u0103ng k\u00eanh KATP, t\u1eeb \u0111\u00f3 thi\u1ebfu h\u1ee5t insulin trong m\u00e1u d\u1eabn t\u1edbi c\u00e1c tri\u1ec7u ch\u1ee9ng \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng. T\u00e1c d\u1ee5ng c\u1ee7a glibenclamide tr\u00ean k\u00eanh KATP gi\u00fap ph\u1ee5c h\u1ed3i kh\u1ea3 n\u0103ng gi\u1ea3i ph\u00f3ng insulin v\u00e0o m\u00e1u. C\u00e1c t\u00e1c d\u1ee5ng n\u00e0y \u0111\u01b0\u1ee3c k\u00ec v\u1ecdng gi\u00fap l\u00e0m gi\u1ea3m c\u00e1c tri\u1ec7u ch\u1ee9ng c\u1ee7a \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng s\u01a1 sinh.<\/p>\n
Hi\u1ec7n nay, \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng s\u01a1 sinh, nh\u1eefng \u0111i\u1ec1u d\u01b0\u1ee1ng ch\u0103m s\u00f3c theo ch\u1ec9 \u0111\u1ecbnh y khoa hay c\u00e1c b\u1eadc cha m\u1eb9 \u1edf nh\u00e0, s\u1eed d\u1ee5ng insulin ho\u1eb7c c\u00e1c vi\u00ean n\u00e9n ch\u1ee9a glibenclamide c\u00f3 s\u1eb5n tr\u00ean th\u1ecb tr\u01b0\u1eddng theo ch\u1ec9 \u0111\u1ecbnh kh\u00f4ng c\u1ea5p ph\u00e9p (ch\u1ec9 \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p cho s\u1eed d\u1ee5ng \u1edf ng\u01b0\u1eddi l\u1edbn). \u0110\u1ec3 ph\u00f9 h\u1ee3p d\u00f9ng cho tr\u1ebb nh\u1ecf, c\u00e1c vi\u00ean n\u00e9n n\u00e0y \u0111\u01b0\u1ee3c nghi\u1ec1n nh\u1ecf r\u1ed3i h\u00f2a v\u1edbi m\u1ed9t \u00edt n\u01b0\u1edbc \u0111\u1ec3 cho tr\u1ebb s\u1eed d\u1ee5ng; h\u1ed7n h\u1ee3p c\u00f3 th\u1ec3 cho u\u1ed1ng b\u1eb1ng xi-lanh. C\u00e1ch l\u00e0m n\u00e0y c\u00f3 th\u1ec3 g\u00e2y sai s\u00f3t trong vi\u1ec7c d\u00f9ng thu\u1ed1c, r\u1ea5t c\u00f3 th\u1ec3 d\u1eabn t\u1edbi nguy c\u01a1 qu\u00e1 li\u1ec1u ho\u1eb7c kh\u00f4ng \u0111\u1ee7 li\u1ec1u. Amglidia \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t cho ph\u00e9p \u0111\u1ecbnh li\u1ec1u glibenclamide ch\u00ednh x\u00e1c h\u01a1n, gi\u1ea3i quy\u1ebft nhu c\u1ea7u n\u00f3i tr\u00ean. Th\u00eam v\u00e0o \u0111\u00f3, b\u1ec7nh nhi \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng Amglidia c\u00f3 th\u1ec3 kh\u00f4ng c\u1ea7n \u0111i\u1ec1u tr\u1ecb th\u00eam b\u1eb1ng insulin ho\u1eb7c li\u1ec1u insulin th\u1ea5p h\u01a1n.<\/p>\n
\u00cdch l\u1ee3i c\u1ee7a Amglidia \u0111\u01b0\u1ee3c minh ch\u1ee9ng b\u1eb1ng c\u00e1c d\u1eef li\u1ec7u y v\u0103n c\u0169ng nh\u01b0 nghi\u00ean c\u1ee9u sinh kh\u1ea3 d\u1ee5ng v\u00e0 nghi\u00ean c\u1ee9u NEOGLI. Do m\u1ee9c \u0111\u1ed9 c\u1ef1c hi\u1ebfm c\u1ee7a b\u1ec7nh, ch\u1ec9 c\u00f3 10 b\u1ec7nh nhi \u0111\u01b0\u1ee3c \u0111\u01b0a v\u00e0o nghi\u00ean c\u1ee9u NEOGLI. Nghi\u00ean c\u1ee9u cho th\u1ea5y vi\u1ec7c ki\u1ec3m so\u00e1t \u0111\u01b0\u1eddng huy\u1ebft v\u1eabn \u1ed5n \u0111\u1ecbnh sau khi \u0111\u1ed5i t\u1eeb vi\u00ean n\u00e9n nghi\u1ec1n sang h\u1ed7n d\u1ecbch u\u1ed1ng.<\/p>\n
Do \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng s\u01a1 sinh l\u00e0 b\u1ec7nh r\u1ea5t hi\u1ebfm, Amglidia \u0111\u01b0\u1ee3c x\u00e9t theo qui tr\u00ecnh d\u00e0nh cho thu\u1ed1c \u0111i\u1ec1u tr\u1ecb b\u1ec7nh hi\u1ebfm v\u00e0o th\u00e1ng 1\/2016. Nh\u01b0 th\u01b0\u1eddng l\u1ec7 v\u00e0o th\u1eddi \u0111i\u1ec3m \u0111\u01b0\u1ee3c x\u00e9t c\u1ea5p ph\u00e9p, qui tr\u00ecnh x\u00e9t duy\u1ec7t n\u00f3i tr\u00ean s\u1ebd \u0111\u01b0\u1ee3c r\u00e0 so\u00e1t b\u1edfi H\u1ed9i \u0111\u1ed3ng v\u1ec1 Thu\u1ed1c \u0111i\u1ec1u tr\u1ecb b\u1ec7nh hi\u1ebfm c\u1ee7a EMA (COMP-EMA) \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh c\u00e1c th\u00f4ng tin s\u1eb5n c\u00f3 hi\u1ec7n nay c\u00f3 cho ph\u00e9p duy tr\u00ec tr\u1ea1ng th\u00e1i d\u00e0nh cho ch\u1eefa tr\u1ecb b\u1ec7nh hi\u1ebfm c\u1ee7a Amglidia v\u00e0 c\u1ea5p ph\u00e9p 10 n\u0103m l\u01b0u h\u00e0nh \u0111\u1ed9c quy\u1ec1n hay kh\u00f4ng.<\/p>\n
\u00dd ki\u1ebfn ch\u1ea5p thu\u1eadn c\u1ee7a CHMP v\u00e0o h\u1ed9i ngh\u1ecb th\u00e1ng 2\/2018 l\u00e0 b\u01b0\u1edbc trung gian tr\u00ean con \u0111\u01b0\u1eddng ti\u1ebfp c\u1eadn v\u1edbi b\u1ec7nh nh\u00e2n c\u1ee7a Amglidia. \u00dd ki\u1ebfn n\u00e0y s\u1ebd \u0111\u01b0\u1ee3c g\u1eedi t\u1edbi \u1ee6y ban ch\u00e2u \u00c2u \u0111\u1ec3 \u0111\u01b0a ra quy\u1ebft \u0111\u1ecbnh c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh tr\u00ean to\u00e0n EU. M\u1ed9t khi \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh, quy\u1ebft \u0111\u1ecbnh v\u1ec1 gi\u00e1 c\u1ea3 v\u00e0 t\u1ec9 l\u1ec7 ho\u00e0n ph\u00ed s\u1ebd \u0111\u01b0\u1ee3c \u0111\u01b0a ra \u1edf c\u1ea5p \u0111\u1ed9 t\u1eebng qu\u1ed1c gia th\u00e0nh vi\u00ean, c\u00f3 x\u00e9t t\u1edbi kh\u1ea3 n\u0103ng v\u1ec1 vai tr\u00f2\/vi\u1ec7c s\u1eed d\u1ee5ng c\u1ee7a thu\u1ed1c trong ho\u00e0n c\u1ea3nh h\u1ec7 th\u1ed1ng y t\u1ebf c\u1ee7a qu\u1ed1c gia \u0111\u00f3.<\/p>\n
Amglidia \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00ed b\u1edfi AMMTeK.<\/p>\n