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Roche: FDA grants breakthrough therapy status to Gazyva

(CercleFinance.com) - Swiss drugmaker Roche said that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Gazyva for the treatment of lupus nephritis, a life-threatening disorder of the kidneys.

Breakthrough therapy designation is designed to accelerate the development and review of medicines intended to treat serious conditions when data proves to be encouraging.

This designation has been granted based on phase II data which showed that Gazyva demonstrated enhanced efficacy compared to placebo plus standard of care in achieving complete renal response at one year.

Lupus nephritis is a complication of lupus, an auto-immune disease where a person's own immune system attacks healthy cells and organs. There is no cure for the disease at present.

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