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October 30, 2017

US FDA grants priority review to AbbVie’s elagolix for endometriosis

The US Food and Drug Administration (FDA) has granted priority review to AbbVie’s investigational candidate, elagolix, for the management of endometriosis with associated pain.

The US Food and Drug Administration (FDA) has granted priority review to AbbVie’s investigational candidate, elagolix, for the management of endometriosis with associated pain.

Endometriosis is characterised by long-term pelvic pain and caused by tissue growth outside of the uterus.

Currently being developed for oral administration, elagolix is a short-acting molecule that competitively binds to receptors of the gonadotropin-releasing hormone (GnRH) in the pituitary gland to block endogenous GnRH signalling.

Upon administration, the candidate is intended to minimise ovarian production of the oestradiol and progesterone hormones by reversibly inhibiting secretion of the luteinizing hormone (LH) and follicle-stimulating hormone (FSH).

“Endometriosis is characterised by long-term pelvic pain and is caused by tissue growth outside of the uterus.”

The priority designation lowers the review period of the drug from the standard ten months to six months from the acceptance of the new drug application (NDA).

AbbVie chief scientific officer and research and development executive vice-president Michael Severino said: “We are pleased that elagolix has been granted priority review by the FDA and will continue to work closely with the agency to hopefully bring this treatment to women suffering from endometriosis as soon as possible.”

The NDA for elagolix is supported by the safety and efficacy findings obtained from prospective randomised clinical trials in approximately 1,700 patients with moderate-to-severe endometriosis-associated pain.

Elagolix is currently being studied in disorders such as uterine fibroids and endometriosis that are mediated by oestradiol and progesterone.

The candidate has already been investigated in a total of more than 3,000 subjects across more than 40 trials.

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