The US FDA has cleared Oriahnn, a new encapsulated estrogen and progestin combination drug for the management of heavy menstrual bleeding associated with uterine leiomyomas or fibroids in premenopausal women.
Oriahnn consists of elagolix, estradiol and norethindrone acetate as active components. The approval of the drug was granted to AbbVie Inc.
Fibroids are the most commonly occurring non-cancerous benign tumours formed in the uterus that can cause heavy menstrual bleeding, pain, bowel or bladder problems and infertility in women. It is one of the most common causes of high menstrual flow in premenopausal women.
Oriahnn was found effective in managing heavy menstrual bleeding in about 76.5% of the patients who participated in the trial.
However the drug may cause bone loss over time, and the US FDA recommends the health care professionals to assess bone density via scan (DXA scan) when starting the course and periodically while on treatment. Oriahnn is recommended not to be taken for more than 24 months as the bone loss may increase the risk for fractures in women.
The drug is contraindicated in women with a history of increased blood clot formation or those who are at-risk, and in women over 35 years of age who smoke and in cases of uncontrolled hypertension.