Dive Brief:
- AbbVie reported more positive data for its recently approved women's health drug, releasing topline results Wednesday from a Phase 3 extension study of patients with uterine fibroids.
- The study showed that, after a year of treatment, elagolix in combination with a low-dose hormone therapy reduced menstrual bleeding, with nearly 88% of women showing a clinical response.
- The Food and Drug Administration approved the drug earlier this year for use in moderate to severe pain in endometriosis, where it is marketed as Orilissa. A submission for uterine fibroids is planned for 2019.
Dive Insight:
Most women in the U.S. will develop fibroids at some point in their life. A quarter of these will have symptoms such as heavy and painful periods, along with vaginal bleeding outside periods. These together can result in anemia.
Existing treatments include surgery, ablation, ultrasound, oral contraceptives, progestins, selective progesterone receptor modulators or GnRH agonists — but often that's not enough, according to AbbVie.
"Women with uterine fibroids are in need of additional medical management options that could help address unresolved symptoms," Dawn Carlson, the company's vice president of general medicine development, said in a statement.
The extension study provides another layer of data to support a 2019 submission for elagolix and could help differentiate the drug from the other interventions available, both surgical and medical.
Before this 12-month extension study, AbbVie completed two pivotal Phase 3 trials where 68.5% and 76.2% of women respectively achieved a clinical response in six months.
Geoffrey Porges of Leerink predicted a 2020 launch for elagolix in uterine fibroids, with 2023 gross sales of $1.7 billion should the second indication be approved, in an investor note that followed the March release of a second set of Phase 3 data.
Porges' only concern is that elagolix comes with hypoestrogenic effects, such as hot flashes and reduction in bone mineral density, which raises a question over whether the drug will be approved for short- or long-term treatment. However, the add-back, low-dose hormone therapy combined with elagolix showed changes from baseline in bone mineral density compared with elagolix alone.
"Endometriosis and fibroids are lifelong conditions for most women, and short or restricted duration treatment intervals are likely to be major limitations for physicians and patients," Porges wrote.
AbbVie won't have to worry about competition from Allergan's Esmya (ulipristal acetate), which picked up a Complete Response Letter from the FDA this week following concerns about the drug's safety. In Europe, there have been post-marketing reports of four cases of serious liver injury, three of which resulted in liver transplantation.