Novartis Secures FDA approval For Fabhalta® As The First Oral Monotherapy For The Treatment Of Adults With Paroxysmal Nocturnal Hemoglobinuria
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Novartis has received FDA approval for Fabhalta, the first oral monotherapy for adults with Paroxysmal Nocturnal Hemoglobinuria (PNH). The approval is based on the APPLY-PNH trial, which showed patients switching to Fabhalta had significant increases in hemoglobin levels compared to those continuing on anti-C5 treatment. Fabhalta is now available for both previously treated and treatment-naïve patients and addresses a significant unmet need in PNH treatment.
December 06, 2023 | 6:21 am
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Novartis has gained FDA approval for Fabhalta, a novel oral treatment for PNH, which could lead to increased market share and revenues in the rare disease treatment space.
FDA approval of a new drug typically has a positive impact on the stock price of the company due to the potential for increased sales and market penetration. Given that Fabhalta is the first oral monotherapy for PNH and addresses a significant unmet medical need, it is likely to be a substantial revenue driver for Novartis in the short term.
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