Pfizer's Cresemba Gains New Intravenous Formulation Approval in China to Address Diverse Clinical Needs in Invasive Mold Infections

ShanghaiJune 20, 2022PR Newswire -- Pfizer Inc. today announced that the National Medical Products Administration has approved the innovative drug Cresemba (isavuconazole sulfate for injection) for the treatment of invasive aspergillosis and invasive mucormycosis in adult patients. This is a new formulation of Cresemba approved in China, following the approval of the capsule formulation. With this approval, Cresemba is now available in China in both oral and intravenous formulations, addressing different treatment scenarios and strategies for invasive fungal infections. By considering the patient’s condition, it provides doctors with more tailored treatment options to meet various clinical needs and benefit patients.

Invasive Aspergillosis and Invasive Mucormycosis: Both Are Invasive Fungal Diseases Often Difficult to Differentiate in Early Diagnosis

As a broad-spectrum novel triazole antifungal agent, the approval of a new formulation of Cresemba (isavuconazole) for the treatment of invasive mucormycosis and invasive aspergillosis in adults will enhance the comprehensive clinical management of invasive fungal infections, providing a new option for critically ill patients and those unable to take oral medications. In the 2017 ECIL-6 Guidelines for Invasive Candidiasis, Aspergillosis, and Mucormycosis in Patients with Leukemia and Hematopoietic Stem Cell Transplantation, isavuconazole is recommended as a first-line treatment for invasive aspergillosis. Additionally, in the 2017 ESCMID-ECMM-ERS Guidelines for the Diagnosis and Management of Aspergillosis, isavuconazole is recommended as a first-line treatment for invasive pulmonary aspergillosis.

Peng Zhenke, President of Pfizer Biopharmaceuticals Group in China, stated, "Pfizer aims to 'bring breakthrough innovations that change patients' lives.' As a company with years of deep cultivation in the anti-infective field, Pfizer is committed to addressing challenges within the infectious disease arena."Unmet Medical Needs. The approval of the new formulation of康新博in China will provide more treatment options for adult patients with invasive mucormycosis and adult patients with invasive aspergillosis, support clinical treatment, and benefit patients in China."

Currently, Kangxinbo has been approved in more than 60 countries and regions, including the United States, the United Kingdom, France, and Switzerland.