AbbVie and Neurocrine have announced the US approval of Orilissa, the first and only oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain.
The companies note that Orilissa (elagolix) is also the first FDA-approved oral treatment for the condition in over a decade, and should be available in US retail pharmacies in early August.
Endometriosis is one of the most common gynaecologic disorders in the US, affecting around one in 10 women of reproductive age.
Studies show that women can suffer from the condition for up to six to 10 years and visit physicians multiple times before receiving a diagnosis and subsequent treatment.
According to the firms, “very few” treatments are specifically indicated for the treatment of endometriosis, and associated pain is often managed with medicines such as oral contraceptives, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids and hormonal therapies, as well as surgery in the most extreme cases.
"Orilissa represents a significant advancement for women with endometriosis and physicians who need more options for the medical management of this disease," said Michael Severino, executive vice president, R&D, and chief scientific officer at AbbVie.
The application was assigned a priority review in December last year, but the FDA said in March that it needed more time to review additional information on liver function tests provided by AbbVie, which it was initially thought would push a decision back till the end of the third quarter.