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Roche wins FDA breakthrough for Gazyva in lupus nephritis

Drug originally approved as a lymphoma treatment


Roche has been granted a breakthrough therapy designation (BTD) from the FDA in the US for its lymphoma medicine Gazyva (obinutuzumab) in lupus nephritis. 

The Swiss pharma company has been aiming to recycle the medicine to target new therapy areas, and it seems like its efforts are beginning to pay off.

The BTD is particularly encouraging given that lupus nephritis is a field were many other candidates have failed to produced meaningful results.

It was based on data from Roche’s phase 2 NOBILITY study in adult patients with proliferative lupus nephritis. This study showed that Gazyva, when combined with the existing standard of care, demonstrated superiority compared to the placebo arm of the study in complete renal response at one year.

The condition is particularly hard-to-treat – it is a form of the autoimmune disease lupus that causes the kidneys to become inflamed, leading to a high risk of end-stage renal disease or death.

Lupus overwhelming affects women, who make up 90% of the patient population. It also has a higher prevalence in women from African, Hispanic and Asian ethnic groups compared to Caucasian women.

There are currently no FDA-approved drugs for the disease – this means that if it is approved, Roche’s therapy will become the only treatment in this area of high unmet need.

“New treatment options are needed for lupus nephritis, a potentially life-threatening inflammation of the kidneys that most commonly affects women,” said Sandra Horning (pictured below), Roche’s chief medical officer and head of global product development.

“We are committed to developing Gazyva as a potential new therapy for lupus nephritis and plan to begin enrolling patients in a phase 3 trial next year,” she added.

Sandra Horning

Sandra Horning

Sales of Gazyva have been modest for Roche so far, bringing in 390m Swiss francs ($393m) in 2018. However, if the Swiss pharma can extend its use into other indications, it could be well on its way to becoming a blockbuster.

Roche has been counting on a new class of medicines to help offset the biosimilar onslaught on its ageing cancer blockbusters, including Herceptin and MabThera/Rituxan.

It has managed to successfully do this thanks to new blockbuster products including Ocrevus (ocrelizumab) for multiple sclerosis and Hemlibra (emicizumab) for haemophilia.

The BTD will mean that the development of Gazyva will be fast-tracked and that it will also have a potential advantage over existing therapies. Roche will also get a priority review for the drug, which can include additional clinical trials and other alternative information to support the application.

Article by
Lucy Parsons

18th September 2019

From: Regulatory



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