First TGA-approved treatment for endometriosis in 13 years

Australia’s drug regulator has approved the first treatment for endometriosis in 13 years to relieve debilitating pain for sufferers of the condition.

On Friday, the Therapeutic Goods Administration (TGA) gave the green light for Ryeqo, a drug supplied by pharmaceutical company Gedeon Richter Australia, to be prescribed by specialists for endometriosis patients.

It is the first oral tablet approved by the TGA to relieve symptoms associated with endometriosis, a condition where tissue similar to lining in the uterus develops in other parts of the body.

The inflammation and scarring from endometriosis causes women to experience symptoms such as pain, heavy menstrual bleeding, fatigue, anxiety, depression, reduced fertility – to name a few. Currently, there is no cure for endometriosis.

Ryeqo is already available in Australia, approved by the TGA to treat symptoms associated with uterine fibroids. However, the TGA has now found sufficient evidence that Ryeqo will be able to relieve pain and reduce excess tissue growth.

This is the first treatment for endometriosis to be TGA-approved in 13 years.

While the approval shows significant progress for women’s health, sufferers of endometriosis might still struggle to access the treatment.

At this stage, Ryeqo is not eligible for the Pharmaceutical Benefits Scheme (PBS) subsidy, a government led initiative that reduces the cost of prescribed medication for Australians.

This means a prescription for Ryeqo could cost patients $135+ every month, according to reports.

Gedeon Ritcher said the company has made a submission to the Pharmaceutical Benefits Advisory Committee (PBAC) to be placed on the PBS list to lower the cost of the medication for endometriosis sufferers.

A debilitating disease

Endometriosis can cause debilitating pain for women, as well as several knock-on effects. In November last year, the University of Queensland found poor mental health was twice as likely for women with endometriosis, as was back pain, and joint pain was 1.5 more likely.

Other symptoms, the researchers found, included bowel and urinary conditions, severe tiredness, difficulty sleeping, allergies, heart palpitations and headaches.

In September last year, research from the Australian Institute of Health and Welfare (AIHW) and the University of Queensland found one in seven women in their late 40s have endometriosis.

The AIHW also reported the rate of hospitalisation for endometriosis doubled among females aged 20-24 in the past decade. While in 2011-12 there were 330 hospitalisations per 100,000 females, this figure rose to 660 per 100,000 in 2021-22.

Over 2021-22, there were 40,500 endometriosis-related hospitalisations, or 312 hospitalisations per 100,000 females.

The inflammation and scarring from endometriosis causes women to experience symptoms such as pain, heavy menstrual bleeding, fatigue, anxiety, depression, reduced fertility – to name a few.

Despite this data showing how common endometriosis is for women, the University of Queensland said it can still take up to 11 years (eight years on average) to receive a formal diagnosis for the condition.

The Australian government is investing in the condition, which affects approximately one in nine people who were assigned female at birth.

In 2018, the federal government announced a National Action Plan for Endometriosis, which invested $87.19 million into awareness, education and clinical management and care for the condition.

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