FABHALTA^® (iptacopan)

FOR IMMEDIATE RELEASE:

FABHALTA (iptacopan) Now Available from Onco360 as the First FDA-Approved Oral Monotherapy Approved for the Treatment of Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH)  

Louisville, KY — December 6, 2023 — Onco360^®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by Novartis for Fabhalta^® (iptacopan) as the first oral monotherapy approved for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).1 Fabhalta^® is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing control of red blood cell destruction within and outside the blood vessels (intra- and extravascular hemolysis).

“Onco360 is grateful for the opportunity to partner with the team at Novartis and become a specialty pharmacy provider for Fabhalta^®”, said Benito Fernandez, Chief Commercial Officer. “We are proud to add the first oral treatment option for PNH patients.”

Patients with PNH have an acquired mutation that makes RBC susceptible to premature destruction by the complement system.² PNH is characterized by bone marrow failure, hemolysis, and thrombosis in varying levels of severity and combinations. Every year, roughly 500 patients in the U.S. are diagnosed with PNH. An estimated 10-16 cases per million patients around the world have PNH.³ Most patients are diagnosed with PNH in their 30s and 40s.

Please see the full Prescribing Information for Fabhalta, including Boxed WARNING and Medication Guide.^®

Media Contact:
Benito Fernandez, Chief Commercial Officer
[email protected]
516-640-1332

References:

1. Iptacopan Prescribing Information. East Hanover, NJ: Novartis Pharmaceuticals Corp; December 2023.
2. Cançado RD, Araújo A da S, Sandes AF, et al. Consensus statement for diagnosis and treatment of paroxysmal nocturnal haemoglobinuria. Hematol Transfus Cell Ther. 2021;43(3):341-348. doi:10.1016/j.htct.2020.06.006
3. Shah N, Bhatt H. Paroxysmal Nocturnal Hemoglobinuria. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK562292