Most of the recent enthusiasm around AbbVie’s new drugs has centered on immunology meds Skyrizi and Rinvoq, but women’s health med elagolix—known commercially as Orilissa in endometriosis—wants a piece of the spotlight, too.
The therapy Friday nabbed an FDA nod to treat heavy menstrual bleeding due to uterine fibroids in pre-menopausal women. Taken alongside estradiol and norethindrone acetate in pill form, it will go by the trade name Oriahnn in the new indication, and it will be the first nonsurgical option for those patients.
Regulators based the decision on data from two phase 3 trials showing the drug could help stop heavy menstrual bleeding in seven out of 10 women, versus just one out of 10 women on placebo. Results also showed Oriahnn could reduce heavy menstrual bleeding by half within the first month of use.
Those improvements are big for patients, not just from a physical perspective but from a psychological one, too, Charlotte Owens, M.D., medical director, general medicine at AbbVie, said ahead of the OK. The normal menstrual cycle is about 25 ml to 45 ml of bleeding each month, but study participants on average saw more than 200 ml each month before starting treatment.
“Imagine the psychological burden that’s also associated with bleeding that much each month, and sometimes in a very unpredictable fashion,” she said. “This really impacts their relationships, day-to-day activities, employment, and not only physical, but mental well-being.”
Uterine fibroids are common, occurring in up to 70% of Caucasian women and in up to 80% of African American women by age 50. About half are symptomatic, leading patients to seek treatment, but the current mainstay of treatment is surgery; fibroids are a leading cause of hysterectomy, Owens said.
With Oriahnn, though, patients will have an FDA-approved alternative “that allows us to have rapid initiation of therapeutic effects, a reduction in bleeding … and have it not only happen quickly, but in a sustained pattern over time while they’re on the therapy, as opposed to having to undergo a significant procedure,” she said.
“As a practicing OB-GYN, this is a game-changer,” she added.
With the regulatory green light out of the way, AbbVie’s big job going forward will be to convince women to seek treatment in the first place. Because the condition is so common, “some women actually normalize this amount of bleeding and … feel like it’s almost a rite of passage.”
“It’s not hard to find someone else who’s gone through this,” Owens said.
The Illinois drugmaker will need to “educate the patients, educate the physicians and introduce them to the new data that we have,” she said, adding, “this should open up the door for more conversations around medical treatment options.”
Those efforts will be underway soon, with the company "planning for a relatively quick launch despite COVID-19 with U.S. commercial availability expected by the end of June 2020," RBC Capital Markets analyst Randall Stanicky wrote in a Friday note to clients.
AbbVie is seeking to bulk up sales before copycats to best-selling Humira hit, and while the $354 million in peak sales Stanicky and his colleagues are modeling for Oriahnn is considerably below what they're expecting to see for AbbVie's new immunology launches, they're not nothing. "Importantly," the approval "signals continued pipeline execution, which is critical as we look ahead" to Humira's 2023 loss of exclusivity in the U.S., he said.
And while the relationship between Oriahnn and sister product Orilissa—which pulled in just $93 million last year after analysts initially heralded it as a 2020 blockbuster candidate—"may give investors pause given the slow ramp" of Orilissa, it shouldn't, Stanicky said.
"We would emphasize that these are two different patient populations and we believe patient activation may be easier for uterine fibroids," he wrote.