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    Home > Medical News > Latest Medical News > The disease's first oral medicine! AbbVie Oriahn approved for uterine fibroid-related menstrual bleeding

    The disease's first oral medicine! AbbVie Oriahn approved for uterine fibroid-related menstrual bleeding

    • Last Update: 2020-06-17
    • Source: Internet
    • Author: User
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    AbbVie and Neurocrine Biosciences recently jointly announced that the U.SFDA has approved Oriahnn (elagolix, estradiol, nonovone ester capsules; elagolix capsules) as the first non-surgical oral drug to treat large amounts of menstrual bleeding associated with uterine fibroids in premenopausal women for up to 24 monthsuterine fibroids, also known as smooth fibroids or fibroids, are estrogen and progesterone-dependent uterine non-cancerous tumors that are non-cancerhormone-reactive muscle tissue tumorsFibroids are the most common type of abnormal growth in women's pelvis and the most common type of benign tumor in women of childbearing age, affecting 70 percent of white women over 50 in the United States and 80 percent of African-American womenThe size, shape, number and position of fibroids can vary during growth and can be asymptomatic, but in some women can cause symptoms such as menstrual bleedingTraditionally, uterine fibroids have been surgically treated (hysterectomy, uterine fibroids), the main cause of hysterectomy in the United StatesOther treatments include endometrial ablation, uterine arterial embolism, magnetic resonance imaging-guided focused ultrasound, and medications such as oral contraceptives, progesterone, selective progesterone receptor regulators, and gonadotropin-releasing hormone (GnRH) agonists and antagoniststhis approval is based on the results of two randomized, double-blind, placebo-controlled Phase 3 clinical trials for uterine fibroids, ELARIS UF-I and ELARIS UF-II, both of which aim to evaluate the effects of elagolix's three-time, 300 mg combined hormone "complementary therapy" (eestrogen 1 mg and acetylene novorone 0.5 mg per day; to replace the decreasing levels of endogenous hormones) in women with intramuscular bloodThe trial was set up to use the elagolix group alone (300 mg twice daily) to assess the effect of co-hormone supplementation therapy on the reduced estrogen effect of elagolixTwo studies in the United States, Canada and other about 100 clinical sites in nearly 800 patients associated with uterine fibroids monthafter after many (severe menstrual bleeding) of premenopausal womenThe main endpoint was measured in the last month of treatment using alkaline hemoglobin, elagolix monodrug or elagolix combination hormone therapy compared to placebo, patients with menstrual blood loss of less than 80 ml, and blood loss from baseline to the last month reduced blood volume by at least 50%A total of 412 women in theUF-1 trial and 378 women in the UF-2 trial were treated in random groups and received elagolix or placeboThe results showed that in the two trials of elagolix joint hormone supplementation therapy group, 68.5% of UF-1 patients met the primary endpoint standard, UF-2 reached the endpoint, and in the elagolix single drug treatment group alone, the proportion of patients who met the end criteria was 84.1% and 77%, respectively, while the proportion of patients in the placebo group who reached the end point standard was 8.7% and 10.00 01% respectivelyElagolix combined hormone therapy is more prone to hot flashes (UF-1 and UF-2) and uterine haemorrhage (in UF-1) than placeboBut hormone therapy weakens the low estrogen effect of elagolix, especially to reduce the density of bone mineralsresearchers published data from two studies in the New England Journal of Medicine and said Oriahn n reached the primary endpoint of clinically meaningful bleeding reduction About 70 per cent of women no longer experience severe menstrual bleeding, compared with only 10 per cent in the placebo group (both trials P were less than 0.001) Oriahnn also reduced the amount of menstrual bleeding caused by uterine fibroids by 50% in the first month after use or or sediton The drug may increase the risk of heart disease, stroke or blood clots, especially those over the age of 35 who smoke and have a history of high blood pressure, the companies said in a statement In addition, The use of Oriahn needs to be limited to 24 months due to the risk of persistent and irreversible bone loss from the drug user Oriahnis is an oral drug consisting of elagolix and E2/NETA (estorinol/acetate) that helps patients balance the risk of reducing heavy bleeding and producing estrogen-related side effects Among them, elagolix is an oral, small molecule GnRH receptor antagonist that releases hormone receptors by inhibiting pituitary pronosin, and ultimately lowers blood circulation neutral gonadotropin levels Elagolix (product name Orilissa) is also a drug developed by AbbVie and Neurocrine Biosciences to treat multi-month symbiosis-related pain in female patients, as well as moderate to severe pain associated with endometriosis Reference Source: FDA Approves The First Oral Oral Medication for The Management of The Management of Heavy Menstrual Bleeding to Uterine Deabe in Pre-mrailAl Women
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