Basilea Pharmaceutica has submitted a marketing authorization application (MAA) under the European decentralized procedure for its novel investigational antibiotic, ceftobiprole, to treat pneumonia in hospitals.
The submission of the application of the broad-spectrum anti-methicillin-resistant Staphylococcus aureus (MRSA) drug is supported by two international double-blind randomized controlled Phase III studies.
Basilea chief executive officer Anthony Man said the submission of the marketing authorization application for ceftobiprole to treat patients in hospital with pneumonia is an important development milestone for the antibiotic.
"Ceftobiprole's antibacterial profile covers a broad spectrum of clinically relevant Gram-positive and Gram-negative pathogens that may cause pneumonia, including MRSA and multidrug-resistant pneumococci," Man added.
The Phase III studies evaluated the efficacy and safety of first- line empiric ceftobiprole versus single or combination drug comparators to treat hospitalized community-acquired and hospital-acquired (nosocomial) pneumonia.
