Policy & Regulation
FDA Notifies AbbVie and Neurocrine Biosciences of Need for Extended Time to Review NDA for Elagolix in Endometriosis-Associated Pain
16 April 2018 - - North Chicago, Illinois-based global biopharmaceutical company AbbVie (NYSE: ABBV) and San Diego, California-based biotechnology company Neurocrine Biosciences, Inc. (NASDAQ: NBIX) have been notified by the US Food and Drug Administration that it requires extended time to review additional information regarding the results of liver function tests provided by AbbVie in connection with its new drug application for elagolix in endometriosis-associated pain, the company said.
The Prescription Drug User Fee Act (PDUFA) date has been extended three months to Q3 2018.
The NDA for elagolix is supported by data from the largest prospective randomized clinical trials conducted to date for endometriosis. The safety and efficacy of elagolix were evaluated in nearly 1,700 women with moderate-to-severe endometriosis-associated pain.
Clinical trial data demonstrated elagolix was well-tolerated and significantly reduced the three types of endometriosis-associated pain daily menstrual pelvic pain, non-menstrual pelvic pain, and painful intercourse.
Elagolix, a gonadotropin-releasing hormone receptor antagonist, is an orally administered, short-acting molecule that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland.
Administration results in readily reversible, dose-dependent inhibition of luteinising hormone and follicle-stimulating hormone secretion, leading to reduced ovarian production of the ovarian sex hormones, estradiol and progesterone, while on therapy.
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for complex and critical conditions.
The company's mission is to improve treatments across four primary therapeutic areas: immunology, oncology, virology, and neuroscience.
Neurocrine Biosciences is focused on neurologic, psychiatric, and endocrine related disorders.
The company markets Ingrezza (valbenazine) capsules in the US for the treatment of adults with tardive dyskinesia.
The company's three late-stage clinical programs are: elagolix, a gonadotropin-releasing hormone antagonist for women's health that is partnered with AbbVie Inc; opicapone, a novel, once-daily, peripherally-acting, highly-selective catechol-o-methyltransferase inhibitor under investigation as adjunct therapy to levodopa in Parkinson's patients; and Ingrezza, a novel, once-daily, selective VMAT2 inhibitor under investigation for the treatment of Tourette syndrome.


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