Gedeon Richter nabs PBAC nod for first endometriosis therapy in over a decade

Pharma News: Gedeon Richter has secured a positive PBAC recommendation for the reimbursement of the first endometriosis treatment in over a decade.

Endometriosis affects 14% of women of reproductive age. Many women with endometriosis-associated pain are not able to manage their pain symptoms with current treatment options, underscoring the high unmet clinical need.

Ryeqo (relugolix, estradiol, norethisterone acetate), a once-daily oral GnRH receptor antagonist, has shown promising results in the SPIRIT 1 and SPIRIT 2 clinical trials. While currently available through private prescription for up to two years, its extension beyond this period necessitates a medical assessment by a gynaecologist.

Glen Pearce, General Manager of Gedeon Richter Australia, said “We are grateful to the PBAC for this positive recommendation and to all Australians who submitted their own experience of endometriosis and the management of endometriosis symptoms as part of the public commentary submission, which provided valuable insights for the PBAC to consider in their decision-making process.”

Australia was the first country in the world to enact a National Action Plan for Endometriosis (NAPE). As the nation enters the fifth and final year of the NAPE, there is a growing consensus on the necessity for its extension.

Nola Marino MP, Deputy Chair of the Joint Standing Committee on the National Capital and External Territories, and co-chair of the Parliamentary Friends Of Endometriosis Awareness, said “At a recent event, we were told about women who currently have to see at least four doctors to get an accurate diagnosis. I understand that only around 5% of GPs are adequately tooled and trained to deal with endometriosis. It can have a profound, debilitating and life-threatening impact.”

Mr Pearce reiterated Gedeon Richter’s commitment to supporting Australians burdened by endometriosis.

“Managing the painful symptoms is fundamental for the estimated 1 million Australian females and assigned female at birth (AFAB) living with the disease to enable them to participate in work and society fully. This improves their economic security, reducing the gender pay gap, and adds to superannuation balances through increased labour force participation,” he stated.

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