The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a licence for Gedeon Richter’s Ryeqo for adults with endometriosis symptoms, making it the first in a new class of treatments authorised in the UK for this patient population. This pivotal decision marks a significant development in the management of endometriosis, a chronic condition that affects approximately 176 million women worldwide.

Endometriosis occurs when tissue similar to the lining of the uterus grows outside of the uterus, causing a range of symptoms such as painful cramping, heavy bleeding, and pelvic pain. The disease can also be associated with sub-fertility or infertility. The MHRA’s decision to license Ryeqo was based on the positive results from the late-stage SPIRIT program, which demonstrated that significantly more patients achieved pain reduction with Ryeqo versus placebo at 24 weeks.

Relugolix Combination Therapy: A New Era in Endometriosis Treatment

Ryeqo, a three-in-one oral daily tablet, is a combination therapy that consists of non-peptide gonadotropin-releasing hormone receptor antagonist relugolix 40mg, estradiol 1mg and norethisterone acetate 0.5mg. The combination therapy is authorized for women of reproductive age who have had prior medical or surgical treatment for their endometriosis.

Effectiveness of Relugolix Combination Therapy

The SPIRIT 1 study demonstrated that 75% of patients responded to Ryeqo for their dysmenorrhoea (painful cramping) compared to 27% in the placebo arm. Similar results were observed in the SPIRIT 2 trial, with 75% of dysmenorrhoea responders in the Ryeqo cohort compared to 30% for placebo.

The SPIRIT program also explored the effectiveness of Ryeqo in reducing non-menstrual pelvic pain (NMPP). In SPIRIT 1, 59% of patients responded to Ryeqo for their NMPP compared to 40% of those receiving placebo. Similar results were observed in SPIRIT 2, with 66% of NMPP responders in the Ryeqo cohort compared to 43% for placebo.

Long-Term Benefits of Relugolix Combination Therapy

Furthermore, a long-term extension study up to 80 weeks found that the relugolix combination therapy enabled participants to experience reduced dysmenorrhoea and NMPP over a two-year period, highlighting the sustained benefits of the treatment.

A Welcome Step for Redefining Care

David Jordan, medical director UK and Ireland, Gedeon Richter, expressed his enthusiasm for the MHRA’s decision, stating that it “is fantastic news and we are delighted the need for more treatment options has been recognised.” He further emphasized the company’s commitment to providing a new way of treating endometriosis for clinicians and women suffering with painful symptoms.

NHS Availability

Gedeon Richter has confirmed that they are actively engaging with the relevant health authorities in the UK with the goal of securing NHS reimbursement as soon as possible. The company anticipates that Ryeqo will be available on the NHS in 2025.

Endometriosis: A Global Challenge

The approval of Ryeqo represents a significant step forward in the global fight against endometriosis. The condition continues to impact the lives of millions of women worldwide, affecting their physical, emotional, and reproductive health.

A New Hope for Endometriosis Patients

The availability of Ryeqo on the NHS will provide women in the UK with a new and effective treatment option for managing their endometriosis-associated pain. This innovative therapy has the potential to significantly improve the quality of life for many women and may contribute to a greater understanding of this complex disease. The ongoing research and development of new treatments for endometriosis are crucial for ensuring that women have access to effective and compassionate care.

Looking Ahead: The Future of Endometriosis Research

While the approval of Ryeqo is a positive development, it is important to recognize that ongoing research and development are crucial for understanding and treating endometriosis. Researchers are actively investigating new biomarkers, treatment approaches, and personalized therapies for this complex condition. The future holds promise for further advancements in the management of endometriosis, ultimately leading to better health outcomes for women worldwide.