AbbVie : Gets FDA OK of Oriahnn for Fibroid-Related Heavy Menstrual Bleeding

By Colin Kellaher

The U.S. Food and Drug Administration approved AbbVie Inc.'s Oriahnn for the management of heavy menstrual bleeding associated with uterine leiomyomas, or fibroids, in premenopausal women.

The agency said Oriahnn, known generically as elagolix, is the first medical treatment option the agency has approved specifically for fibroid-related heavy menstrual bleeding.

AbbVie last August filed a new drug application for Oriahnn in cooperation with Neurocrine Biosciences Inc., which in 2010 formed an exclusive collaboration with fellow biopharmaceutical company AbbVie to develop and commercialize elagolix for women's and men's health.

AbbVie, based in North Chicago, Ill., biopharmaceutical company, is responsible for all development, marketing and commercialization costs, while San Diego-based Neurocrine is entitled to a royalty on worldwide sales.

AbbVie in 2018 received FDA approval of elagolix as Orilissa for women with moderate to severe endometriosis pain.

Write to Colin Kellaher at [e-mail]