Basilea superbug drug application accepted by authorities

Ceftobiprole, an anti-MRSA antibiotic, was granted fast track designation by the FDA.

The regulatory dossiers were submitted by Basilea’s co-development partner Johnson & Johnson in the US and in Europe by its license partner Janssen-Cilag.

“This underscores the potential of this new antibiotic in the treatment of complicated skin and skin structure infections in which MRSA or gram-negative pathogens are a concern. In addition, we plan to report topline data for the pneumonia program, including hospital-acquired and community-acquired pneumonia requiring hospitalization, later this year,” commented Dr Anthony Man, CEO of Basilea.