Li\u1ec7u ph\u00e1p gene Luxturna (voretigene neparvovec-rzyl) \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p cho \u0111i\u1ec1u tr\u1ecb m\u1ed9t d\u1ea1ng gi\u1ea3m th\u1ecb l\u1ef1c hi\u1ebfm g\u1eb7p Luxuric (voretigene neparvovec-rzyl) c\u1ee7a h\u00e3ng Spark Therapeutics l\u00e0 m\u1ed9t c\u1ea5p ph\u00e9p mang t\u00ednh l\u1ecbch s\u1eed cho li\u1ec7u ph\u00e1p gene \u0111\u1ea7u ti\u00ean d\u00f9ng \u0111\u01b0\u1eddng tr\u1ef1c ti\u1ebfp nh\u1eafm \u0111\u1ebfn b\u1ec7nh l\u00fd g\u00e2y ra do \u0111\u1ed9t bi\u1ebfn gen \u0111\u1eb7c hi\u1ec7u. S\u1ea3n ph\u1ea9m n\u00e0y d\u00f9ng cho ng\u01b0\u1eddi m\u1eafc b\u1ec7nh l\u00ed v\u00f5ng m\u1ea1c di truy\u1ec1n do \u0111\u1ed9t bi\u1ebfn l\u01b0\u1ee1ng allele RPE65, \u0111\u00e2y l\u00e0 m\u1ed9t d\u1ea1ng gi\u1ea3m th\u1ecb l\u1ef1c c\u00f3 th\u1ec3 g\u00e2y m\u00f9 l\u00f2a. Luxturna l\u00e0 li\u1ec7u ph\u00e1p gen qua vector AVV (virus g\u1eafn adenovirus) d\u00f9ng \u0111\u01b0\u1eddng ti\u00eam d\u01b0\u1edbi v\u00f5ng m\u1ea1c \u0111\u1ec3 ph\u00e2n ph\u1ed1i tr\u1ef1c ti\u1ebfp b\u1ea3n sao b\u00ecnh th\u01b0\u1eddng c\u1ee7a gen RPE65. Nghi\u00ean c\u1ee9u pha III cho th\u1ea5y b\u1ec7nh nh\u00e2n c\u1ea3i thi\u1ec7n \u0111\u00e1ng k\u1ec3 so v\u1edbi nh\u00f3m ch\u1ee9ng trong vi\u1ec7c ho\u00e0n th\u00e0nh b\u00e0i t\u1eadp v\u01b0\u1ee3t ch\u01b0\u1edbng ng\u1ea1i v\u1eadt d\u01b0\u1edbi \u00e1nh s\u00e1ng c\u01b0\u1eddng \u0111\u1ed9 th\u1ea5p.<\/p>\n
FDA \u0111\u00e3 c\u1ea5p ph\u00e9p Giapreza (angiotensin II) d\u1ea1ng truy\u1ec1n t\u0129nh m\u1ea1ch c\u1ee7a h\u00e3ng La Jolla Pharmaceutical cho \u0111i\u1ec1u tr\u1ecb n\u00e2ng huy\u1ebft \u00e1p \u1edf ng\u01b0\u1eddi tr\u01b0\u1edfng th\u00e0nh b\u1ecb s\u1ed1c nhi\u1ec5m khu\u1ea9n ho\u1eb7c c\u00e1c d\u1ea1ng s\u1ed1c ph\u00e2n b\u1ed1 th\u1ec3 t\u00edch kh\u00e1c. \u0110\u00e2y l\u00e0 ch\u1ea5t co m\u1ea1ch angiotensin II t\u1ed5ng h\u1ee3p t\u1eeb ng\u01b0\u1eddi. Trong nghi\u00ean c\u1ee9u \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh tr\u00ean 321 b\u1ec7nh nh\u00e2n b\u1ecb s\u1ed1c k\u00e8m t\u1ee5t huy\u1ebft \u00e1p n\u1eb7ng, so v\u1edbi nh\u00f3m gi\u1ea3 d\u01b0\u1ee3c t\u1ec9 l\u1ec7 b\u1ec7nh nh\u00e2n \u0111\u00e1p \u1ee9ng v\u1edbi \u0111i\u1ec1u tr\u1ecb cao h\u01a1n \u0111\u00e1ng k\u1ec3 \u1edf nh\u00f3m d\u00f9ng Giapreza. Giapreza c\u00f3 t\u00e1c d\u1ee5ng n\u00e2ng huy\u1ebft \u00e1p khi ph\u1ed1i h\u1ee3p v\u1edbi c\u00e1c bi\u1ec7n ph\u00e1p n\u00e2ng huy\u1ebft \u00e1p th\u01b0\u1eddng qui (b\u00f9 d\u1ecbch, thu\u1ed1c v\u1eadn m\u1ea1ch nh\u01b0 c\u00e1c catecholamine v\u00e0\/ ho\u1eb7c vasopressin). Giapreza c\u00f3 th\u1ec3 t\u1ea1o ra c\u00e1c c\u1ee5c huy\u1ebft kh\u1ed1i nguy hi\u1ec3m g\u00e2y h\u1eadu qu\u1ea3 nghi\u00eam tr\u1ecdng; do \u0111\u00f3 c\u1ea7n s\u1eed d\u1ee5ng c\u00e1c bi\u1ec7n ph\u00e1p d\u1ef1 ph\u00f2ng huy\u1ebft kh\u1ed1i.<\/p>\n
Rhopressa (netarsudil) d\u1ea1ng dung d\u1ecbch nh\u1ecf m\u1eaft c\u1ee7a h\u00e3ng Aerie Pharmaceuticals d\u00f9ng 1 l\u1ea7n\/ng\u00e0y \u0111\u00e3 \u0111\u01b0\u1ee3c FDA-US c\u1ea5p ph\u00e9p cho \u0111i\u1ec1u tr\u1ecb l\u00e0m gi\u1ea3m nh\u00e3n \u00e1p \u1edf b\u1ec7nh nh\u00e2n glaucoma g\u00f3c m\u1edf. \u0110\u00e2y l\u00e0 m\u1ed9t ch\u1ea5t \u1ee9c ch\u1ebf Rho kinase, c\u00f3 t\u00e1c d\u1ee5ng l\u00e0m gi\u1ea3m nh\u00e3n \u00e1p b\u1eb1ng c\u00e1ch l\u00e0m t\u0103ng tho\u00e1t th\u1ee7y d\u1ecbch. Rhopressa s\u1ebd c\u00f3 m\u1eb7t tr\u00ean th\u1ecb tr\u01b0\u1eddng Hoa K\u00ec v\u00e0o qu\u00ed II n\u0103m 2018.<\/p>\n
FDA-US \u0111\u00e3 c\u1ea5p ph\u00e9p thu\u1ed1c Ozempic (semaglutide) c\u1ee7a h\u00e3ng Novo Nordisk, m\u1ed9t ch\u1ea5t t\u01b0\u01a1ng t\u1ef1 GLP-1 cho \u0111i\u1ec1u tr\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng type 2. Thu\u1ed1c \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p cho 2 d\u1ea1ng li\u1ec1u 0,5 mg v\u00e0 1 mg, v\u00e0 \u0111ang ti\u1ebfn t\u1edbi ph\u00e1t tri\u1ec3n th\u00e0nh d\u1ea1ng b\u00fat ti\u00eam t\u1ef1 \u0111\u1ed9ng Ozempic. Trong nghi\u00ean c\u1ee9u pha III, Ozempic cho th\u1ea5y t\u00e1c d\u1ee5ng l\u00e0m gi\u1ea3m HbA1c so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c, v\u1edbi sitagliptin v\u00e0 exenatide d\u1ea1ng gi\u1ea3i ph\u00f3ng k\u00e9o d\u00e0i; \u0111\u1ed3ng th\u1eddi c\u00f2n cho th\u1ea5y t\u00e1c d\u1ee5ng gi\u1ea3m c\u00e2n. C\u00e1c t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n hay g\u1eb7p nh\u1ea5t l\u00e0 bu\u1ed3n n\u00f4n, n\u00f4n, ti\u00eau ch\u1ea3y, \u0111au b\u1ee5ng v\u00e0 t\u00e1o b\u00f3n.<\/p>\n
Trong th\u00e1ng 12 v\u1eeba qua, FDA-US c\u0169ng \u0111\u00e3 c\u1ea5p ph\u00e9p thu\u1ed1c Steglatro (ertugliflozin) c\u1ee7a h\u00e3ng Pfizer v\u00e0 Merck, thu\u1ed1c m\u1edbi thu\u1ed9c nh\u00f3m \u1ee9c ch\u1ebf SGLT2, c\u00f9ng v\u1edbi 2 thu\u1ed1c ph\u1ed1i h\u1ee3p m\u1edbi ch\u1ee9a ertugliflozin l\u00e0 Segluromet (ertugliflozin ph\u1ed1i h\u1ee3p v\u1edbi thu\u1ed1c nh\u00f3m biguanide l\u00e0 metformin), v\u00e0 Steglujan (ertugliflozin ph\u1ed1i h\u1ee3p v\u1edbi thu\u1ed1c nh\u00f3m \u1ee9c ch\u1ebf dipeptidyl peptidase-4 l\u00e0 sitagliptin). \u1ede pha III, Steglatro \u0111\u01b0\u1ee3c nghi\u00ean c\u1ee9u \u1edf d\u1ea1ng \u0111\u01a1n \u0111\u1ed9c v\u00e0 d\u1ea1ng ph\u1ed1i h\u1ee3p v\u1edbi metformin v\u00e0\/ ho\u1eb7c sitagliptin, c\u0169ng nh\u01b0 v\u1edbi insulin v\u00e0 m\u1ed9t thu\u1ed1c nh\u00f3m sulfonylurea. Steglatro ph\u1ed1i h\u1ee3p v\u1edbi metformin ho\u1eb7c sitagliptin l\u00e0m gi\u1ea3m \u0111\u00e1ng k\u1ec3 HbA1c t\u01b0\u01a1ng \u1ee9ng \u1edf m\u1ee9c 0,7% v\u00e0 0,8% so v\u1edbi m\u1ee9c 0,2% \u1edf nh\u00f3m gi\u1ea3 d\u01b0\u1ee3c, v\u00e0 gi\u1ea3m c\u00e2n n\u1eb7ng kho\u1ea3ng 6,2 \u0111\u1ebfn 6,6 pound (kho\u1ea3ng 2,8 \u0111\u1ebfn 3,0 kg).<\/p>\n