AbbVie wins an approval in uterine fibroid-associated heavy bleeding. Are rivals Myovant and ObsEva far behind?
Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.
Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.
Now, elagolix in combination with two hormone drugs — estradiol and norethindrone acetate — has been approved by the FDA. AbbVie will sell the twice-daily regimen as Oriahnn.
“In the absence of head-to-head comparisons … it’s really hard for us to compare and contrast with drugs that are currently in development right now,” said Charlotte Owens, medical director of general medicine at AbbVie, in an interview.
Oriahnn’s approval was based on two six-month pivotal studies — each study required the regimen to generate a statistically significant impact on reducing blood loss by at least 50% in patients. Each study also had an elagolix monotherapy arm.
In one late-stage study, 68.5% (p<0.001) of elagolix combo-treated women with uterine fibroids hit that goal compared to placebo (8.7%), in the second trial 76.2% elagolix combo-treated women achieved the endpoint compared to placebo (10.1%). However, the drug’s side effect profile caused pause largely due to the loss of bone density in patients who received the AbbVie drug.
Analysts have suggested the ObsEva and Myovant therapies could have an edge over the AbbVie drug, if approved. But the two rivals will have been beaten to market and neither have the commercial prowess that a behemoth like AbbVie can boast of.
ObsEva has tested its GnRH drug linzagolix in patients with and without ABT. Late last year, the Swiss drugmaker posted data from the PRIMROSE 2 trial, which tested two doses of the drug against a placebo. The results showed 93.9% for women receiving 200 mg of the drug with ABT trial saw more than 50% reduction in bleeding, and 56.7% for women receiving 100 mg without ABT achieved the same goal, compared to 29.4% in the placebo group.
Although analysts have been encouraged by the positive data in patients who responded well to the drug despite the lack of ABT (women predisposed to high BMI, CV risk and diabetes are typically not prescribed ABT) in the drug’s safety profile, particularly bone density loss, did vex investors. The company has another pivotal study that is expected to read out in the coming months.
Meanwhile, Myovant Sciences is also in the mix with its offering: relugolix. The drug, like the AbbVie regimen, is designed for use in combination with ABT. Currently under FDA review, the regimen was also tested in two phase III studies, with the same main goal: 50% or more reduction in blood loss.
In one study, 71.2% of women receiving relugolix regimen achieved the clinical response they were looking for, compared to only 14.7% in the control arm. In the other, 73.4% of women on the relugolix arm achieved the same goal, compared with 18.9% of women receiving placebo. Crucially, though, Myovant’s did no significant differences in terms of bone mineral density.
“The response rates demonstrated in these trials were comparable to those shown by AbbVie’s approved GnRH inhibitor, Orilissa, while maintaining a stable bone mineral density profile with a once-daily option,” Baird’s Brian Skorney wrote in a note earlier this month.
Endpoints News has contacted AbbVie for comment on Oriahnn pricing.