Swiss Regulatory Authority Grants Accelerated Assessment of Planned Market Authorization Application for Ceftobiprole
Basilea Pharmaceutica Ltd. announced that Swissmedic granted Janssen-Cilag AG, a Johnson & Johnson company, accelerated assessment of the planned market authorization application ("Beschleunigtes Zulassungsverfahren") for ceftobiprole for the treatment of complicated skin and soft tissue structure infections.
Swissmedic accelerated assessment designation is designed to expedite the availability of treatments that address high medical needs and is granted provided all of the following criteria are fulfilled: the therapy must have promising potential for the treatment of a severely debilitating or life-threatening disease, existing therapies are insufficient or not available, and a high therapeutic benefit is expected through the use of the drug.
Ceftobiprole (BAL5788), Basilea's lead antibacterial product is specially designed to bind the penicillin-resistant targets in many Gram-positive cocci, resulting in bactericidal activity towards methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumoniae (PRSP). Ceftobiprole has demonstrated a broad-spectrum profile targeting other Gram-positive as well as Gram-negative pathogens. In addition it has shown a low potential to select resistance in vitro.
Organizations
Other news from the department research and development

Get the life science industry in your inbox
By submitting this form you agree that LUMITOS AG will send you the newsletter(s) selected above by email. Your data will not be passed on to third parties. Your data will be stored and processed in accordance with our data protection regulations. LUMITOS may contact you by email for the purpose of advertising or market and opinion surveys. You can revoke your consent at any time without giving reasons to LUMITOS AG, Ernst-Augustin-Str. 2, 12489 Berlin, Germany or by e-mail at revoke@lumitos.com with effect for the future. In addition, each email contains a link to unsubscribe from the corresponding newsletter.