Studied in more than ONE type of patient

Studied in a broad range of women, including patients like yours

Selected patient characteristics at baseline in ELARIS UF-1 and UF-2 (N=790)1-7†

Fibroid Location

  • Submucosal
  • Intramural
  • Subserosal

Primary Fibroid
Volume

Mean

79.6 cm3

Range

1-1081.5 cm3

Primary fibroid volume defined as largest fibroid identified by ultrasound.

Uterine Volume

Mean

500.0 cm3

Range

71.6-3347.9 cm3

A uterus that is 14-16 weeks in size is approximately 355-460 cm3.

Age

Mean

42.4 years

Range

25-53 years

MBL Volume

Mean

239.7 mL

Range

83.8-1207.1 mL

1 cup=237 mL

MBL=menstrual blood loss

BMI

Mean

33.6 kg/m2

Range

18.8-61.5 kg/m2

Comprised of

68%

Black or African American women1

AND

15%

Hispanic or Latina women4

How was ORIAHNN studied?

In two 6-month Phase 3 pivotal studies (ELARIS UF-1 AND UF-2) including premenopausal women aged 25-53 with heavy menstrual bleeding associated with uterine fibroids and in an additional
6-month extension study (UF-EXTEND), which did not include a placebo arm1,8,9

Evaluated across
multiple endpoints

Primary endpoint in ELARIS UF-1, UF-2, and UF-EXTEND1,8,9:

The proportion of women who attained both menstrual blood loss (MBL) volume less than 80 mL at the Final Month‡§ and 50% or greater reduction in MBL volume from baseline to the Final Month‡§

Ranked secondary endpoints in ELARIS UF-1 and UF-21,8,9:

  • Change in MBL volume from baseline to Months 1, 3, 6, and Final Month
  • Number and percentage of women with Suppression of Bleeding (defined as no bleeding, but spotting allowed) during the Final Month of treatment
  • Number and percentage of women with baseline hemoglobin ≤10.5 g/dL who saw an increase of >2 g/dL at Month 6

The same secondary endpoints were studied in the extension study (ELARIS UF-EXTEND), but were not ranked

ORIAHNN met the primary endpoint and all 6 ranked secondary endpoints in its pivotal studies9

*The ORIAHNN free trial provides a single 28-day trial supply of ORIAHNN at no cost to new patients residing in the United States with a valid prescription for an FDA-approved indication of ORIAHNN and who enroll in Oriahnn Complete. The trial is intended solely to allow new patients not currently taking ORIAHNN to determine with their healthcare provider whether ORIAHNN is right for them. There is no obligation to continue use of ORIAHNN after the trial has concluded and this program does not guarantee insurance coverage. Eligible patients are limited to one 28-day trial supply and may not re-enroll. The ORIAHNN trial supply will be dispensed only through an AbbVie-authorized pharmacy to the patient’s home address and may not be sold or further distributed. No claims for payment may be submitted to any third party insurance plan for product dispensed by program. AbbVie reserves the right to change or discontinue the trial at any time without notice. The trial is not health insurance and is not a discount, coupon, rebate or financial assistance program. Limitations may apply.

For primary fibroid volume only, N=778.

Final Month in ELARIS UF-1 and UF-2 is defined as the last 28 days before and including the last treatment visit date or the last dose date.

§Final Month in ELARIS UF-EXTEND is defined as the last 28 days before and including the last dose date.