Linzagolix for endometriosis: comparative data are lacking

Endometriosis is currently not curable. There are, however, various approaches to treating the often major symptoms of affected women: The drug dienogest, GnRH analogues such as goserelin, buserelin, leuprorelin, triptorelin or nafarelin, the fixed combination of relugolix/estradiol/norethisterone acetate, or surgery promise relief.

The (German-language) report was published in March 2025, an English translation in May 2025.

Since November 2024, physicians have had another treatment option at their disposal: linzagolix. This drug is approved for adult women of childbearing age who have already had medical or surgical treatment. The treatment combines linzagolix with the hormones estradiol and norethisterone acetate.

Women with endometriosis and their physicians naturally would now like to understand whether linzagolix has any advantages or disadvantages compared with existing standard treatments. The Institute for Quality and Efficiency in Health Care (IQWiG) has investigated this question as part of a benefit assessment: Does linzagolix have an added benefit for endometriosis patients when compared with the appropriate comparator therapy?

“There are already various options to relieve the symptoms of endometriosis. Nevertheless, new drugs are still only being compared with placebo,” Daniela Preukschat, Head of the Chronic Diseases Division in IQWiG’s Drug Assessment Department, criticizes. “That is disappointing for patients because they don’t know whether the new treatment provides more help than the existing ones.”

The problem with placebo comparisons is already known from other therapeutic indications, such as ulcerative colitis, and endometriosis is just another example, Preukschat adds. As a result, she says, there is once again no suitable data available for the benefit assessment.

Preukschat: “The proportion of projects without suitable data has remained high since the AMNOG procedure started – overall, we can hardly see any positive development here. This is why effective incentives are finally needed to encourage manufacturers to generate comparative data.”

The G-BA decides on the extent of added benefit

The dossier assessment is part of the early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the Federal Joint Committee (G-BA). After publication of the dossier assessment, the G-BA conducts a commenting procedure and makes a final decision on the extent of the added benefit.