NICE endorses Theramex's GnRH antagonist Yselty for uterine fibroids

The UK's National Institute for Health and Care Excellence (NICE) has endorsed Theramex’s Yselty (linzagolix) as a treatment for moderate-to-severe symptoms of uterine fibroids in adult women of reproductive age. This endorsement allows the oral gonadotropin-releasing hormone (GnRH) receptor antagonist to be prescribed routinely through the NHS in England and Wales.

Yselty has secured approval in the EU and UK since 2022, following two Phase III PRIMROSE trials, establishing it as the first GnRH antagonist that offers a non-hormonal treatment option for women with uterine fibroids. Jonathan Benger, NICE's chief medical officer, emphasized that linzagolix provides greater flexibility, as it can be administered with or without hormone therapy, enabling clinicians to offer more personalized care.

NICE has specified that Yselty is recommended exclusively for longer-term use, exceeding six months. It is deemed inappropriate for short-term treatment, such as pre-surgical intervention for uterine fibroids. The medication's annual list price is set at £1097.20 ($1410) with hormonal add-back therapy and £1040.00 ($1336) without it.

NICE estimates that about one-third of women will develop symptomatic uterine fibroids during their lifetime. In England and Wales alone, up to 30,000 women could potentially benefit from this new treatment option. Tina Backhouse, UK general manager at Theramex, stated that the company is committed to collaborating with NICE and the NHS to ensure that as many women as possible have access to this treatment.

Initially developed by Kissei Pharmaceutical, the GnRH antagonist was licensed to ObsEva in 2015 for commercialization outside of Asia. In 2022, Theramex entered into an agreement with ObsEva to support the drug’s commercialization in regions excluding the US, Canada, and Asia. However, ObsEva encountered regulatory challenges with the FDA concerning the drug’s approval in the US, leading to a strategic reorganization and the assignment of Theramex as Kissei’s licensing partner outside of Asia.