Switzerland’s Basilea Pharmaceutica has been boosted by the news that local regulators have backed the firm’s superbug antibiotic ceftobiprole.
Basilea and partner Johnson & Johnson say that Swissmedic has granted approval for ceftobiprole, which will be marketed as Zevtera, for the treatment of complicated skin and soft tissue infections including diabetic foot infections. The drug is a first-in-class broad-spectrum anti-methicillin-resistant staphylococcus aureus (MRSA) in the cephalosporin class.
Basilea noted that the Swiss marketing authorisation certificate can be used to facilitate regulatory approval in emerging markets, including those in Asia and South America. Chief executive Anthony Man noted that the approval is “an important moment for our company and brings a novel and effective treatment against resistant bacteria to patients and physicians here in Switzerland”.
Zeftera received its first approval in June from Canada and is under review in the USA and European Union. In March, the US Food and Drug Administration issued an approvable letter for the drug and requested more information on its impact on diabetic foot infections, as well as more time to evaluate the clinical data in the file and inspect study sites.
However, the FDA did not ask for any additional trials to be carried out and analysts believe a US approval could be given at the beginning of 2009. Markus Metzger, an analyst at Vontobel, issued a research note saying that the approval from Swissmedic is “in-line with our and market expectations but certainly bodes well for the anticipated approval of ceftobiprole in Europe later this year and in the important US market by Q1 2009”.
