China NMPA Approves NUZYRA as a Category 1 Innovative Drug for the Treatment of Patients with Community-Acquired Bacterial Pneumonia (CABP) and Acute Bacterial Skin and Skin Structure Infections (ABSSSI) - Seite 2

NUZYRA was approved by the U.S. Food and Drug Administration (FDA) for both CABP and ABSSSI based on comprehensive clinical trial programs involving more than 2,000 patients and, since 2019, it has been marketed in the United States by Paratek Pharmaceuticals, Inc. In 2017, while NUZYRA was still in its clinical stage, Zai Lab in-licensed the rights to NUZYRA for the Greater China region (mainland China, Hong Kong, Macau, and Taiwan). Since then, Zai Lab conducted three clinical trials involving Chinese patients in support of NUZYRA’s registration in mainland China.

About CABP and ABSSSI

CABP is the most common type of pneumonia that is acquired outside the hospital. It is one of the most common infectious diseases and is an important cause of mortality and morbidity worldwide. ABSSSI are bacterial infections of skin and associated soft tissues, such as loose connective tissue and mucous membranes. ABSSSI are common and encompass a variety of disease presentations and degrees of severity. In 2015, the estimated incidences of ABSSSI and CABP were 2.8 million patients and 16.5 million patients, respectively, in China alone. Linezolid and moxifloxacin are the current standards of care for ABSSSI and CABP, respectively. There are significant unmet needs for broad-spectrum antibiotics addressing MDR infections with a favorable safety profile.

About NUZYRA

NUZYRA (omadacycline), a novel tetracycline-class antibacterial with both once-daily oral and IV formulations, is specifically designed to overcome tetracycline resistance and to improve activity across a broad spectrum of bacterial infections, such as those caused by Gram-positive, Gram-negative, atypical, and many other pathogens. NUZYRA was launched in the United States in February 2019 as a once-daily oral and intravenous antibiotic for the treatment of adults with CABP and ABSSSI. It was approved in June 2021 by the FDA as an oral-only dosing regimen for the treatment of adults with CABP.

Important Safety Information

NUZYRA is structurally similar to other drugs of the tetracycline class and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action that has led to increased blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis, and elevated liver enzymes have been reported for other tetracycline-class antibacterial drugs and may occur with NUZYRA. Physicians and patients should discontinue use of NUZYRA if any of these adverse reactions are suspected.