Armed with new phase 3 data, AbbVie is planning to file Orilissa for uterine fibroids, just a few weeks after getting approval for the drug in endometriosis pain.
The results of two phase 3 trials showed that a six months’ treatment with oral Orilissa (elagolix) reduced heavy menstrual bleeding associated with uterine fibroids compared to placebo when added to standard low-dose hormone therapy.If approved for this indication, AbbVie will be a big step further on the path of turning the product into a blockbuster brand, say analysts, and closer to its goal of reducing its reliance on $16bn immunology blockbuster Humira (adalimumab), due to face biosimilar competition in Europe later this year and in the US in 2023.
In the first trial, 68.5% of women on elagolix achieved the threshold clinical response to treatment, compared to 8.7% of the placebo group. The results of the second trial were very similar, at 76.2% and 10.1%, respectively, and for both studies, results showed improvements in patient-reported symptom severity and quality of life. AbbVie says it is now planning to file its first applications for the drug in uterine fibroids in mid-2019.
Uterine fibroids are non-cancerous tumours that form in the muscle walls of the uterus and affect between 20% and 80% of women by the age of 50. In many cases they cause no symptoms, but around a quarter of women experience pain, abnormal bleeding and other symptoms, and may experience fertility problems.
AbbVie in-licensed the drug from Neurocrine in 2010 for $575 million, and on approval by the FDA for endometriosis in July became the first new oral treatment for that indication in the US for more than a decade. Neurocrine pocketed a $40m milestone payment on approval.
It launched at a list price of $845 per month, above the $7,000 annual threshold for cost-effectiveness set by the Institute for Clinical and Economic Review (ICER) in its report on the drug, but could fall to that level with rebates and discounts.
AbbVie hasn’t revealed sales yet, but said on its third-quarter results call that take-up is “tracking right in line with our assumptions, with broad formulary coverage expected by early 2019.” It’s planning a major direct-to-consumer (DTC) advertising campaign to support the roll-out in the US.