Novartis has shared positive results from a phase 3b study of Fabhalta (iptacopan) in a new population of patients with the ...

Iptacopan (Fabhalta) is the first medicine approved for C3G in adults to lower protein in the urine. Fabhalta is a medicine that blocks factor B of the alternative complement system, which is ...

During the trial, none of the participants needed blood transfusions, and 92.7% of them reached Hb levels of at least 12g/dL.

EAST HANOVER, N.J., March 20, 2025 /PRNewswire/ -- Novartis today announced that oral Fabhalta® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of ...

In the Phase IIIB APPULSE-PNH study, adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who switched to Fabhalta experienced clinically meaningful improvements in hemoglobin (Hb) levels of ...

Novartis has a third FDA-approved indication for its oral therapy for complement-mediated diseases – Fabhalta – after getting a green light in ultra-rare kidney disease C3 glomerulopathy (C3G).

have recommended reimbursement of Fabhalta in the treatment of adult patients with PNH who have an inadequate response to, or are intolerant of, a C5 inhibitor 5,6 Novartis Pharmaceuticals Canada ...

Findings from the APPEAR-C3G trial showed a 35% reduction in 24-hour UPCR from baseline (primary endpoint) in the iptacopan group compared with the placebo group. The Food and Drug Administration ...

Novartis’ kidney disease troika keeps marching forward. With a new FDA approval, the company’s Fabhalta has become the first treatment endorsed by the agency for the ultrarare kidney disease ...

The affirmative regulatory decision is the third for Novartis’s Fabhalta, building up the drug’s pipeline-in-a-product potential. But competition looms from a rival drug taking a similar approach.

EAST HANOVER, N.J., March 20, 2025 /PRNewswire/ -- Novartis today announced that oral Fabhalta (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults ...