Switzerland’s Basilea Pharmaceutica has moved closer to getting its new antibiotic ceftobiprole approved in the USA.
The company said that the drug, the first broad-spectrum cephalosporin to show efficacy in a large clinical trial against methicillin-resistant Staphylococcus aureus (MRSA), has been assigned a review by the US Food and Drug Administration’s Anti-Infective Drug Advisory Committee on February 28. Basilea is hoping to get approval of ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections.
Ceftobiprole is being co-developed with Johnson & Johnson, which submitted the NDA for ceftobiprole. The J&J unit Janssen-Cilag submitted a marketing authorisation application to the European Medicines Agency last June.
Approval for a drug for MRSA would be a major boost for Basilea and would be financially lucrative. The firm also has high hopes for alitretinoin, an oral treatment of severe chronic hand eczema which was filed with the Canadian health regulator NDS just before Christmas. It has already been filed for approval in Switzerland and the European union.
