Rezdiffra (resmetirom) ໄດ້ຮັບການອະນຸມັດໂດຍ FDA ຂອງສະຫະລັດອາເມລິກາສໍາລັບການປິ່ນປົວຜູ້ໃຫຍ່ທີ່ມີ steatohepatitis noncirrhotic ທີ່ບໍ່ມີເຫຼົ້າ (NASH) ທີ່ມີຮອຍແປ້ວຕັບປານກາງເຖິງກ້າວຫນ້າ (fibrosis), ເພື່ອນໍາໃຊ້ພ້ອມກັບອາຫານແລະການອອກກໍາລັງກາຍ.
ຈົນກ່ວາໃນປັດຈຸບັນ, ຄົນເຈັບທີ່ມີ steatohepatitis noncirrhotic ທີ່ບໍ່ມີເຫຼົ້າ (NASH) ທີ່ມີຮອຍແປ້ວຕັບທີ່ໂດດເດັ່ນຍັງບໍ່ມີຢາທີ່ສາມາດແກ້ໄຂໄດ້ໂດຍກົງ. ຄວາມເສຍຫາຍຕັບ. FDA ຂອງ approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise.
NASH is a result of the progression of non-alcoholic fatty ຕັບ ພະຍາດ ບ່ອນທີ່ ຕັບ inflammation, over time, can lead to liver scarring and liver dysfunction. NASH is often associated with other health problems such as high blood pressure and type 2 diabetes. By at least one estimate, approximately 6-8 million people in the U.S. have NASH with moderate to advanced liver scarring, with that number expected to increase.
Rezdiffra ເປັນຕົວກະຕຸ້ນບາງສ່ວນຂອງ receptor ຮໍໂມນ thyroid; ການກະຕຸ້ນຂອງ receptor ນີ້ໂດຍ Rezdiffra ໃນຕັບຫຼຸດຜ່ອນການສະສົມໄຂມັນຕັບ.
ຄວາມປອດໄພແລະປະສິດທິພາບຂອງ Rezdiffra
The safety and efficacy of Rezdiffra was evaluated based on an analysis of a surrogate endpoint at month 12 in a 54-month, randomized, double-blind placebo-controlled trial. The surrogate endpoint measured the extent of ຕັບ inflammation and scarring. The sponsor is required to conduct a postapproval study to verify and describe Rezdiffra’s clinical benefit, which will be done through completing the same 54-month study, which is still ongoing. To enroll in the trial, patients needed to have a ຕັບ biopsy showing inflammation due to NASH with moderate or advanced ຕັບ scarring. In the trial, 888 subjects were randomly assigned to receive one of the following: placebo (294 subjects); 80 milligrams of Rezdiffra (298 subjects); or 100 milligrams of Rezdiffra (296 subjects); once daily, in addition to standard care for NASH, which includes counseling for healthy diet and exercise.
At 12 months, liver biopsies showed that a greater proportion of subjects who were treated with Rezdiffra achieved NASH resolution or an improvement in liver scarring as compared with those who received the placebo. A total of 26% to 27% of subjects who received 80 milligrams of Rezdiffra and 24% to 36% of subjects who received 100 milligrams of Rezdiffra experienced NASH resolution and no worsening of liver scarring, compared to 9% to 13% of those who received placebo and counseling on diet and exercise. The range of responses reflects different pathologists’ readings. In addition, a total of 23% of subjects who received 80 milligrams of Rezdiffra and 24% to 28% of subjects who received 100 milligrams of Rezdiffra experienced an improvement in ຕັບ scarring and no worsening of NASH, compared to 13% to 15% of those who received placebo, depending on each pathologist’s readings. Demonstration of these changes in a proportion of patients after just one year of treatment is notable, as the ພະຍາດ typically progresses slowly with most patients taking years or even decades to show progression.
ຜົນຂ້າງຄຽງຂອງ Rezdiffra
ຜົນຂ້າງຄຽງທີ່ພົບເລື້ອຍທີ່ສຸດຂອງ Rezdiffra ລວມທັງການຖອກທ້ອງແລະປວດຮາກ. Rezdiffra ມາພ້ອມກັບຄໍາເຕືອນແລະຂໍ້ຄວນລະວັງບາງຢ່າງເຊັ່ນ: ພິດຕັບຍ້ອນຢາເສບຕິດແລະຜົນຂ້າງຄຽງທີ່ກ່ຽວຂ້ອງກັບຕ່ອມຂົມ.
Use of Rezdiffra should be avoided in patients with decompensated cirrhosis. Patients should stop using Rezdiffra if they develop signs or symptoms of worsening ຕັບ function while on Rezdiffra treatment.
ປະຕິສໍາພັນຂອງຢາເສບຕິດ Rezdiffra
ການໃຊ້ Rezdiffra ໃນເວລາດຽວກັນກັບຢາອື່ນໆບາງຊະນິດ, ໂດຍສະເພາະຢາ statins ສໍາລັບການຫຼຸດລົງຂອງ cholesterol, ອາດຈະສົ່ງຜົນໃຫ້ເກີດປະຕິສໍາພັນກັບຢາທີ່ສໍາຄັນ. ຜູ້ໃຫ້ບໍລິການດ້ານສຸຂະພາບຄວນອ້າງອີງໃສ່ຂໍ້ມູນການສັ່ງຢາຢ່າງເຕັມທີ່ສໍາລັບຂໍ້ມູນເພີ່ມເຕີມກ່ຽວກັບປະຕິສໍາພັນຂອງຢາທີ່ມີທ່າແຮງເຫຼົ່ານີ້ກັບ Rezdiffra, ປະລິມານທີ່ແນະນໍາແລະການດັດແກ້ການບໍລິຫານ.
ໄດ້ ອາຫານແລະຢາ approved Rezdiffra under the accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions and address an unmet medical need, based on a surrogate or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. The required aforementioned 54-month study, which is ongoing, will assess clinical benefit after 54 months of Rezdiffra treatment.
Rezdiffra ໄດ້ຮັບການປິ່ນປົວດ້ວຍ Breakthrough, Fast Track ແລະການທົບທວນບູລິມະສິດການອອກແບບສໍາລັບການຊີ້ບອກນີ້.
ໄດ້ ອາຫານແລະຢາ granted the approval of Rezdiffra to Madrigal Pharmaceuticals.
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ທີ່ມາ:
FDA 2024. ການປ່ອຍຂ່າວ – FDA ອະນຸມັດການປິ່ນປົວຄັ້ງທໍາອິດສໍາລັບຄົນເຈັບທີ່ມີບາດແຜຕັບເນື່ອງຈາກພະຍາດຕັບໄຂມັນ. ຂຽນເມື່ອວັນທີ 14 ມີນາ 2024. ມີຢູ່ https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-liver-scarring-due-fatty-liver-disease
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