TGA approves new medication for treatment of endometriosis symptoms

<span>Ryeqo is the first oral tablet approved by the TGA for endometriosis pain and also works to prevent excess tissue growth. </span><span>Photograph: Getty Images</span>
Ryeqo is the first oral tablet approved by the TGA for endometriosis pain and also works to prevent excess tissue growth. Photograph: Getty Images

The first new endometriosis treatment in 13 years – aimed at relieving the debilitating pain many with the condition suffer – has been approved by Australia’s drug regulator.

Endometriosis is a chronic condition that occurs when tissue similar to the lining of the uterus grows outside it, affecting other organs and leading to inflammation, lesions and scar tissue.

The condition affects at least one in nine girls and women. About 15 out of every 1,000 hospitalisations among women aged 15–44 in Australia are endometriosis-related.

Related: ‘Outdated pseudoscience’: women still being told having a baby will cure endometriosis, Australian study finds

There is no cure, and diagnosis is often delayed for years.

While treatments include pain-relief medication, hormone therapy, surgery and combined treatments, not all of these are effective for all sufferers.

On Friday, pharmaceutical company Gedeon Richter Australia announced Ryeqo, a once-daily tablet, had been approved by the Therapeutic Goods Administration for the treatment of symptoms associated with endometriosis.

It is the first oral tablet approved by the TGA for endometriosis pain and also works to prevent excess tissue growth.

However, the drug will not be subsidised by the Pharmaceutical Benefits Scheme, which means a prescription will cost patients $135 or more for a one-month supply. Eligible patients will need a prescription from their specialist and the drug can be prescribed for up to two years.

Gedeon Richter has made a submission to the Pharmaceutical Benefits Advisory Committee [PBAC] for the drug to be considered for reimbursement and a decision will be made at PBAC’s March meeting.

Ryeqo is already available in Australia, as it is approved to treat symptoms associated with uterine fibroids and doctors do already sometimes prescribe it “off-label” (when a drug is prescribed outside the conditions it is approved by the TGA to treat) for endometriosis.

Approval of Ryeqo means the TGA is satisfied there is enough evidence for its efficacy in treating endometriosis symptoms.

Related: Australian women with endometriosis face six-year wait for diagnosis, study finds

The director of Monash University’s women’s health research program, Prof Susan Davis, said “as an endocrinologist it is a great option to combine a treatment that blocks the normal ovarian cycle and provides a constant low dose estrogen-progestogen replacement to prevent or reduce estrogen deficiency symptoms”.

But she said it is important to note it may not work for every woman.

Prof Gino Pecoraro, a gynaecologist and endometriosis specialist with The Wesley hospital in Brisbane, said it nonetheless “provides another option for treating the life-impacting symptoms experienced by women living with this condition”.

“I often see patients who have been suffering unnecessarily for too long, they are fed up and looking for answers to manage their endometriosis pain,” he said.

CEO of Endometriosis Australia, Maree Davenport, said it is also important that a new drug that is not an oral contraceptive is now approved.

“This new drug is an is another tool to enable women with endometriosis to manage their pain, and while it might not suit everybody, for many from culturally and linguistically diverse backgrounds, this drug means that the taboo issues relating to going on contraceptives to manage endometriosis pain is alleviated.”