- AbbVie Inc. and partner Neurocrine Biosciences Inc. revealed April 10 that the Food and Drug Administration will need more time to review their application for approval of elagolix, a treatment for endometriosis-associated pain.
- The agency pushed the so-called user fee action date for elagolix back by three months, delaying a decision on approval until the third quarter.
- AbbVie said the FDA required further time to evaluate additional data from liver function tests provided to the regulator by the biopharma. The companies noted a planned regulatory submission for the drug in uterine fibroids remains on track.
Elagolix, an oral gonadotropin-releasing hormone receptor antagonist, could be one of the first new oral medications to treat endometriosis-associated pain if approved. Analysts project the drug could bring in over $1 billion in sales by 2022.
AbbVie signed on to develop the drug with Neurocrine in June 2010. Then part of Abbott Laboratories, the biopharma paid $75 million upfront, and agreed to $500 million in development, regulatory and commercial milestones. The drug originally had a user fee action date set for this month.
Neurocrine shares fell by about 4% in value during Tuesday morning on the news, while AbbVie shares rose by more than 2% — possibly in reaction to an announcement April 9 concerning an important pipeline candidate for arthritis.
The women's health space has seen several clinical setbacks of late. Allergan plc disclosed in March the FDA delayed a decision on its uterine fibroid drug ulipristal acetate to August due to four cases of liver toxicity discovered in patients in Europe. Ulipristal originally had a user fee action date in the first half of 2018.
The drug, which is already marketed in Europe under the name Esmya, showed no signs of liver function issues in clinical trials. But the European Medicines Agency's Pharmacovigilance Risk Assessment Committee is currently investigating safety issues and has recommended that no new patients be prescribed the drug.
While ulipristal has a different mechanism of action than elagolix, both drugs limit the production of the progesterone hormone.
AbbVie has only presented topline data from the Phase 3 studies of elagolix in uterine fibroids and expects to present those data in full at an upcoming medical meeting. There was no mention by the company in any prior data releases for elagolix of liver function issues.
The most common adverse events seen in trials of the drug were hot flush, headache and nausea.