AbbVie Inc (NYSE:ABBV) together with Neurocrine Biosciences, Inc. (NASDAQ:NBIX) has revealed that they have received notice from the Food and Drug Administration (FDA) that the review process for their uterine drug will take more time.
The notice involves marketing review of a drug called Elagolix as a treatment option for pain associated with endometriosis as revealed by the two companies. The FDA in its notice said that it needed more time to complete the review and it also requested more information from the liver function trials to add on to the previous information that AbbVie had already provided.
The FDA is expected to reveal its verdict on the review in Q3 of 2018, meaning the request for more time will push back the final decision by an extra three months. AbbVie and Neurocrine started working on elagolix in 2010. The development took a lot of time but they managed to secure a priority review destination towards the end of 2017. This means that their NDA for the drug was scheduled for approval in Q2 of 2018.
“Based on our review of the data, we remain confident in our New Drug Application for elagolix in the treatment of endometriosis-associated pain. 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,” stated AbbVie’s Executive Vice President of research and development, Michael Severino.
AbbVie has been optimistic about the regulatory review especially because the data provided to support the NDA comes from the possibly the largest randomized clinical trials that have ever been carried out for endometriosis. The latter is a disease in which tissue that grows inside the uterus starts growing on the outer part of the uterus.
The clinical data provided by the two companies indicates that Elagolix was well tolerated and that it demonstrated significant reduction. About 1,700 suffering from mild to severe endometriosis pains were involved in the clinical trial to explore the safety and efficacy characteristics of the treatment.
AbbVie stock closed the latest trading session on Tuesday at $93.62.