AbbVie’s elagolix has been slated as a blockbuster-in-the-making by analysts predicting big things for the potential treatment for uterine fibroids and endometriosis.
Hopes on this front have been boosted by further Phase 3 results that have indicated that AbbVie stands in a good position to go in front of the FDA for an indication in uterine fibroids.
In the Elaris trial, elagolix met its primary endpoint of reducing heavy menstrual bleeding in 76.2% of women, when used alongside a low-dose hormone therapy. This compared strongly against placebo, which managed such a reduction in only 10% of patients.
Clinical response was based on a guideline of a 50% or greater reduction in menstrual blood loss volume compared to baseline, at the six month mark.
According to AbbVie’s press release, approximately 80% of women may be affected by uterine fibroids by the age of 50 and, in 25% of patients, this will manifest in painful symptoms.
“Millions of women currently diagnosed with uterine fibroids are faced with limited non-surgical options,” said Dawn Carlson, Vice President, General Medicine Development. “The results from this study demonstrate elagolix has the potential to be an important oral treatment option for women suffering from uterine fibroids.”
Only last month, AbbVie posted similarly strong results in another Phase 3 study on the drug’s use in the same condition.
An NDA for elagolix has already been submitted by AbbVie for the treatment of endometriosis, with a decision expected during the second quarter. A submission to follow for an indication in uterine fibroids was mentioned in the press release and will be based on the data from the two trials, with the full data to be presented at an upcoming medical conference.
It is expected that the drug could hit $1.2 billion in peak sales should the treatment be approved in both indications.