Novartis' new PNH drug Fabhalta is set to land in Korea.

According to industry sources, Novartis Korea has submitted an application for the marketing authorization of its Paroxysmal Nocturnal Hemoglobinuria (PNH) drug Fabhalta (iptacopan) to the Ministry of Food and Drug Safety. Therefore, the drug is expected to be approved within this year.

After receiving approval from the US Food and Drug Administration (FDA) at the end of the past year, the company is also undergoing review processes for Fabhalta’s approval in Europe and Japan.

Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing comprehens