The competitive landscape for PNH has seen significant shifts, particularly with the introduction of Fabhalta (Novartis), which launched in December 2023, alongside newer market entrants Voydeya ...

The March meeting of the EMA’s human medicines committee (CHMP) saw an approval recommendation for Novartis’ Fabhalta, on track to become the first oral monotherapy for rare disease paroxysmal ...

In its approved use in PNH, Fabhalta already competes with Empaveli, a twice-weekly infusion from Apellis Pharmaceuticals that blocks the complement system protein C3. The two drugs could also ...

The FDA has approved Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria.

Carla Nester, MD, MSA, FASN, is coinvestigator for the ongoing APPEAR-C3G trial (NCT04817618), data from which were used to ...

Fabhalta received its first FDA approval in December 2023 for adults with paroxysmal nocturnal hemoglobinuria (PNH). In the fourth quarter of 2024, Fabhalta generated sales of $57 million.

EXTON, PA, March 18, 2025 (GLOBE NEWSWIRE) -- Paroxysmal Nocturnal Hemoglobinuria (PNH) is a rare and debilitating blood disorder that affects approximately 8,000 to 10,000 people in North America ...

The competitive landscape for PNH has seen significant shifts, particularly with the introduction of Fabhalta (Novartis), which launched in December 2023, alongside newer market entrants Voydeya ...