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The FDA announcement was announced in April 10th. FDA requires a lengthening of the review time to fully assess the effect of the drug on the liver function of patients in the elagolix application data for the treatment of endometriosis related pain new drugs. The PDUFA will be delayed for 3 months to the third quarter of 2018.
AI Bo Wei submitted the NDA of elagolix in September 2017 and obtained the priority of FDA qualification after more than 1 months. The initial approval date is April 27, 2018, and is expected to be the first drug to treat endometriosis related pain in women in more than 10 years.
Elagolix is an oral gonadotropin releasing hormone (GnRH) receptor antagonist that blocks the GnRH signaling pathway through a competitive combination of GnRH receptors in the pituitary gland, and reverses the secretion of ovarian sex hormones, estradiol and progesterone. To date, Elagolix has been validated in more than more than 3000 patients in more than 40 clinical studies.
The basis for Elagolix’s listing is the largest prospective and randomized clinical trial conducted in patients with endometriosis so far. The results of more than 1700 women with moderate and severe endometriosis associated pain showed that elagolix was well tolerated and significantly relieved three types of endometriosis related pain in the menstrual period, such as pelvic pain, non menstrual pelvic pain, and sexual pain.
Michael Severino, executive vice president of Ai Bowei, said: “based on our assessment of clinical data, we still have strong confidence in elagolix’s approval of the treatment of endometriosis related pain, which is expected to bring new governance options for women suffering from endometriosis.”
Endometriosis is a female common gynecologic disease that is grown outside the endometrium with active endometrium. It can lead to long-term pelvic pain (including menstrual and non menstrual pain), sexual intercourse pain, and other types of pain. There is no cure. Conventional pain management drugs include oral contraceptives, progestin, nonsteroidal anti-inflammatory drugs, GnRH agonists and so on, but most drugs are not used exclusively for the treatment of endometriosis.
Elagolix was one of the most noteworthy new drugs in 2018, and EvaluatePharma predicted that elagolix’s 2022 sales could reach US $1 billion 210 million.

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