Pfizer's antifungal drug "isavuconazole" approved in China

Article source: Pharmaceutical Guanlan

On December 16, China's National Medical Products Administration (NMPA) announced the latest announcement that the marketing application for isavuconazole sulfate capsules, a new anti-infective drug introduced by Pfizer, has been approved

Screenshot source: NMPA official website

Invasive mycosis is a common complication with high morbidity and mortality in immunocompromised patients, such as those with advanced HIV infection and cancer

The advent of isavuconazole provides an important new treatment option for those suffering from this life-threatening fungal infection

Public information shows that isavuconazole inhibits the demethylation of 14α-lanosterol mediated by cytochrome P450 (CYP), which inhibits the synthesis of ergosterol in the fungal cell membrane and accumulates the toxic intermediate lanosterol, resulting in the accumulation of lanosterol in the fungal cell membrane.

According to literature reports, isavuconazole has a broad antibacterial spectrum, and in vitro studies and clinical trials have shown that it has antibacterial activity against molds, yeasts, bidirectional fungi and some rare fungi; it is effective for clinical treatment of infections in special parts, such as the central nervous system; Its blood concentration is stable, its safety and tolerability are good, and its long-term drug-related adverse reactions are few

In the United States, isavuconazole is marketed by Astellas, an authorized partner of Baseria Pharma

Note: The original text has been deleted

References:

[1] China State Food and Drug Administration’s December 16 Drug Approval Document Pending Information.

[3] Pfizer signs agreement to develop and sell CRESEMBA® (isavuconazole) in China and Asia Pacific.