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Roche gets breakthrough designation for 'Gazyva' lupus treatment

By Josh White

Date: Wednesday 18 Sep 2019

Roche gets breakthrough designation for 'Gazyva' lupus treatment

(Sharecast News) - Roche announced on Wednesday that the US Food and Drug Administration (FDA) has granted 'Breakthrough Therapy Designation' (BTD) to 'Gazyva' (obinutuzumab) for adults with lupus nephritis.
The Swiss drugmaking giant said the designation was granted based on data from the phase 2 'NOBILITY' study in adult patients with proliferative lupus nephritis, which showed Gazyva - in combination with standard of care, being mycophenolate mofetil or mycophenolic acid and corticosteroids - demonstrated enhanced efficacy compared to placebo plus standard of care alone in achieving complete renal response at one year.

Roche described lupus nephritis as a potentially life-threatening manifestation of systemic lupus erythematosus, resulting from inflammation of the kidneys, adding that it was associated with a high risk of end-stage renal disease or death.

Breakthrough Therapy Designation was designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions with preliminary evidence that indicated they may demonstrate a "substantial improvement" over existing therapies, it added.

It was the 27th BTD achieved for Roche's portfolio of medicines.

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

"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."

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