FDA ok for new option for bleeding associated with fibroids in women

The US Food and Drug Administration on Friday granted approval to Oriahnn (an estrogen and progestin combination product consisting of elagolix, estradiol and norethindrone acetate) capsules, co-packaged for oral use, for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

According to US pharma major AbbVie (NYSE: ABBV), the drug’s developer, Oriahnn is the first FDA-approved non-surgical, oral medication option for the management of heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. Oriahnn is expected to be available in the USA by the end of June 2020.

The main ingredient in the combination, elagolix was approved by the FDA in 2018, under the trade name Orilissa, as a treatment for moderate-to-severe pain associated with endometriosis. This was developed by AbbVie in conjunction with Neurocrine Biosciences (Nasdaq: NBIX).