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.
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial