Novartis: FDA approves treatment for C3G

(CercleFinance.com) - Novartis announced that oral Fabhalta (iptacopan) has received approval from the US FDA for the treatment of adults with C3 glomerulopathy (C3G).
It is the first and only approved treatment for C3 glomerulopathy (C3G).

The Phase III study showed a sustained reduction in proteinuria at one year, with favorable safety.

C3G is an ultra-rare, progressive kidney disease which, until now, has had no approved treatment, it says.

Around half of people with C3G progress to kidney failure within 10 years of diagnosis, requiring lifelong dialysis and/or kidney transplantation.

Fabhalta's approval is historic for the entire C3G community, as we now have, for the first time, a treatment that is intended to treat the underlying cause of the disease, offering the possibility of a new standard of care for patients, the co-investigator said.

Finally having an approved treatment that can be taken orally is something C3G sufferers have been eagerly awaiting. Today's approval is a new source of hope for many.


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