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

Novartis has unveiled further data for Fabhalta (iptacopan), reinforcing its position in the paroxysmal nocturnal ...

Novartis Fabhalta shows statistically significant and clinically meaningful improvements in haemoglobin in new population of patients with PNH: Basel Friday, June 13, 2025, 09:00 ...

Novartis' Fabhalta improved hemoglobin, reduced fatigue and eliminated transfusion need in a Phase 3B PNH study presented at the 2025 EHA Congress.

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 ...

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.

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 ...

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 ...

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 ...

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 ...

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 ...

Patients treated with Fabhalta reported an average improvement in fatigue from baseline of 4.88 points at Day 84 and 4.29 points at Day 168 of the study (as measured by FACIT-Fatigue score) 1 "Today, ...