Basilea Pharmaceutica announced today that the FDA has issued an approvable letter for its first-in-class anti-MRSA agent cephalosporin for which company sought an indication to treat skin infections and diabetic foot infections.
According to the company, prior to approval the FDA wants "completion and assessment of clinical study site inspections; assessment of clinical and microbiological data provided but not yet reviewed; and further characterization of patients with diabetic foot infections."
The FDA can extend PDUFA dates by 90 days to review data that has not yet been reviewed – apparently that may not be enough time – hence the approvable letter.
The investigational product was submitted with partner Johnson & Johnson and is also under review in Canada, Switzerland and the European Union. J&J has not issued a release.
According to CNN Money, shares of Basilea dropped 25% at the news.