AbbVie is gunning for the second indication for its new women’s health product Orilissa, hoping to add uterine fibroids to its FDA approval last year in endometriosis-related pain.
The active ingredient in Orilissa – oral gonadotropin-releasing hormone (GnRH) antagonist elagolix – has been submitted to the FDA as a treatment for heavy menstrual bleeding associated with uterine fibroids, which are non-cancerous, hormonally-responsive muscle tissue tumours in the uterus.
The marketing application comes on the back of two phase 3 trials, involving nearly 800 women, which showed that adding elagolix to low-dose hormone therapy resulted in a significant reduction in menstrual blood loss compared to placebo.
As was the case with the endometriosis indication, the efficacy gain came with a trade-off in the form of an increase in menopausal side effects such as hot flushes and night sweats, despite the use of a so-called ‘add-back’ therapy with hormone drugs to minimise those symptoms.
That raises the question of whether women will be prepared to tolerate the menopausal side effects in order to tackle the relatively short-term symptoms of uterine fibroids.
Some analysts bet that they will, and have tipped elagolix to become a $1bn-plus product in endometriosis alone, with an upside if it gets a green light in the uterine fibroids indication as well.
However, AbbVie is facing some competition in the category from Myovant’s rival drug relugolix, which has just chalked up positive phase 3 trials in uterine fibroids and will set up a regulatory filing before the end of the year.
Relugolix has results in uterine fibroids that look similar to elagolix, and Myovant is also suggesting its drug offers better tolerability and improved convenience with once-daily dosing versus twice-daily with AbbVie’s drug.
The jury is out on whether Myovant can compete with AbbVie’s marketing muscle if both drugs get the go-ahead for uterine fibroids, although at least one analyst – Cowen’s Phil Nadeau – thinks it can and that relugolix will become a $1bn-plus product. Takeda has rights to the drug in some Asian markets.
Elagolix’s filing is also good news for Neurocrine Biosciences, from which AbbVie licensed the drug in 2010 for $575m.