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Novartis Gets Priority Review for Kidney Disease Treatment

By Ben Glickman


Novartis said it received priority review for Fabhalta as a potential treatment for IgA nephropathy, a rare kidney disease.

The pharmaceutical company said Monday that its submission to the U.S. Food and Drug Administration for potential accelerated approval of its treatment had been accepted. The company's IgA nephropathy treatment has received priority review, the company said, which means regulators are aiming to act on the application within six months.

The company's treatment Fabhalta is being evaluated in a Phase 3 trial. An interim analysis found a clinically meaningful and statistically significant reduction in proteinuria, a surrogate marker which correlates to progression to kidney failure.

Accelerated approval from the FDA allows for drugs that treat a serious condition with an unmet medical need to be approved using surrogate endpoints, or an indirect marker believed to predict a clinical effect.

Fabhalta received FDA approval in December 2023 to treat adults with the rare blood disorder paroxysmal nocturnal hemoglobinuria.


Write to Ben Glickman at


(END) Dow Jones Newswires

April 15, 2024 14:40 ET (18:40 GMT)

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