NICE approves Ryeqo for endometriosis treatment in the UK

UK— The National Institute for Health and Care Excellence (NICE) in the UK has approved Gedeon Richter’s Ryeqo (relugolix–estradiol–norethisterone) for use within the National Health Service (NHS).

This medication will provide a once-daily oral treatment option for individuals with endometriosis, presenting an alternative to current treatments.

Ryeqo works by blocking the gonadotrophin-releasing hormone (GnRH), which plays a role in the development of endometriosis, while simultaneously providing the necessary hormone replacement.

Unlike traditional GnRH agonists such as Takeda’s Prostap (leuprorelin) and AstraZeneca’s Zoladex (goserelin), which are typically limited to six months of use, Ryeqo can be taken until menopause. This makes it a more flexible long-term option for managing symptoms.

According to NICE, approximately 1,000 women per year could benefit from Ryeqo, which costs £72(US$ 93.09) per 28-day pack.

Helen Knight, director of medicines evaluation at NICE, emphasized the convenience of a daily pill, noting that it eliminates the need for frequent clinic visits for injections.

Additionally, the ability to start and stop treatment more easily is particularly beneficial for women who are planning to have children or managing side effects.

Endometriosis is a chronic condition where tissue similar to the lining of the womb grows outside the uterus, leading to severe pain, heavy periods, fatigue, and fertility challenges. Current treatment options include pain relief, hormonal therapy, and surgery.

Ryeqo is now available for patients who have previously tried medical or surgical treatments without success and for whom alternatives like tranexamic acid, hormonal contraceptives, and intrauterine devices were ineffective or unsuitable.

NICE’s final draft guidance highlights the need for long-term, non-invasive treatment options, given that endometriosis has no cure.

 While charities such as Endometriosis UK welcomed the decision, they cautioned that Ryeqo induces a state of “medical menopause” alongside hormone replacement therapy (HRT), meaning it may only be suitable for a small proportion of the estimated 1.5 million women affected by the disease in the UK.

NICE had initially been hesitant to approve Ryeqo but reversed its decision after Gedeon Richter provided additional evidence demonstrating the drug’s effectiveness and cost-efficiency.

Clinical trials, including the Phase III SPIRIT 1 (NCT03204318) and SPIRIT 2 (NCT03204331) studies, which involved over 1,200 women, showed that Ryeqo significantly reduced endometriosis-related pain and was well tolerated compared to a placebo.

Beyond the approval of new treatments, Endometriosis UK continues to advocate for greater investment in research to better understand the condition, improve management strategies, and ultimately find a cure.

At the Royal Society of Medicine’s Innovation in Women’s Health and Femtech meeting on 3 March 2025, McKinsey partner Anouk Petersen highlighted the disparity in funding.

Despite affecting about 10% of women, the same proportion of the population as diabetes, endometriosis receives eight to ten times less funding.

A report from McKinsey & Company and the World Economic Forum further emphasized the economic impact of conditions like endometriosis.

While women generally live longer than men, they spend 25% more of their lives managing debilitating health conditions.

This has significant productivity consequences, with 60% of the gender health gap occurring during prime working years, contributing to 80% of the economic burden on gross domestic product (GDP).

According to GlobalData’s Pharma Intelligence Center, Ryeqo is forecast to generate up to US$775 million in sales by 2030.

 Its approval represents an important step in expanding treatment options for endometriosis, but continued efforts are needed to address the broader challenges surrounding the condition.

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