Janssen Korea will discontinue the supply of its antifungal drug Sporanox Solution (itraconazole).
On Tuesday, the company reported the supply stoppage of Sporanox Solution to the Ministry of Health and Welfare.
The liquid-type itraconazole is indicated for treating oral and/or esophageal candidiasis in HIV-positive or other immunosuppressed patients and for the prevention of deep-seated fungal infections susceptible to itraconazole when standard therapy is inappropriate for patients with hematologic malignancies or bone marrow transplantation who are expected to be neutropenic (<500/μL).
Janssen Korea said that the suspension of the supply of Sporanox Solution is due to the manufacturer, Janssen Pharmaceutica N.V., 's decision to discontinue production. Accordingly, Janssen Korea will also withdraw its marketing authorization for Sporanox Solution.
The withdrawal of Sporanox is expected to have a minimal impact on patient care, as many antifungal products on the market have similar mechanisms of action and efficacy to Sporanox. Ninety-two itraconazole-based products, including Sporanox, are licensed in various formulations.
The anticipated date of discontinuation of Sporanox Solution is July 31.
"We are supplying the market with the remaining inventory after the importation of Sporanox on Nov. 30, 2023, and the last supply date is July 31, 2024, based on the current sales trend," Janssen Korea said.
Although the marketing authorization for Sporanox will be withdrawn at the end of 2024, the company added that the remaining stocks on the market will be available to patients as needed until July 2025, the expiration date of the current imported medicinal product.
