The FDA is pushing back the PDUFA date for AbbVie and Neurocrine's drug for endometriosis-linked pain by three months, saying it needs more time to review the results of liver function tests. The agency is now expected to make a decision on the candidate in the third quarter this year.
The pair teamed up on elagolix in 2010, back when AbbVie was still part of Abbott. The pharma company took over development, forking over $75 million up front, with an additional $500 million in milestone payments on the line. The treatment nabbed a priority review designation at the end of 2017, setting it up for a Q2 approval.
The NDA for elagolix is based on what AbbVie calls the largest prospective randomized clinical trials that have been conducted for endometriosis, a disease where tissue that normally grows inside the uterus begins to grow outside that organ. About 1,700 women with moderate to severe endometriosis were enrolled in two studies, which reported topline results in February 2016. The drug is also being evaluated in the treatment of uterine fibroids.
"We are pleased with the outcomes of the pivotal trials thus far. AbbVie will continue to pursue Elagolix as a potential new treatment for the disease's most common symptoms, including pain related to menstruation and chronic pelvic pain throughout the menstrual cycle," said Michael Severino, chief scientific officer at AbbVie, at the time.
Trial data showed that 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.
"Based on our review of the data, we remain confident in our New Drug Application for elagolix in the treatment of endometriosis-associated pain," Severino said. "Elagolix has the potential to be an important new treatment option for women suffering from endometriosis and we are committed to working with the FDA to bring this therapy to patients."