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FDA Approves Oral Tx for PNH – FABHALTA

……………catching up on FDA approvals

The FDA approved a new ORAL therapy, Fabhalta (iptacopan) from Novartis, the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).  Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system. It provides comprehensive control of red blood cell (RBC) destruction within and outside the blood vessels (intra- and extravascular hemolysis [IVH and EVH]). 

PNH is characterized by hemolysis, bone marrow failure, and thrombosis in varying combinations and levels of severity.  Up to 88% of patients on legacy treatment may have persistent anemia with over one-third of those patients requiring blood transfusions at least once per year. Nearly all patients treated with Fabhalta did not require blood transfusions.

Was approved with a Black Box Warning — FABHALTA increases the risk of serious and life-threatening infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B.

The wholesale acquisition cost for Fabhalta is $26,900 for one month supply.

Since its approval, Novartis has confirmed that Fabhalta is being dispensed by at least two specialty pharmacies, Onco360 and Biologics by McKesson.

CLICK HERE to access prescribing information


Novartis receives FDA approval for Fabhalta (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH

CLICK HERE to read the full press release


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