RxTrials Institute Drug Pipeline Alert

Approvable Letter for MRSA Treatment (Eye on FDA)
In his blog, Mark Senak writes about the approvable letter Basilea Pharmaceutica received from the FDA for its anti-methicillin-resistant Staphylococcus aureus agent cephalosporin for which the 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,’” Senak writes.

The product also is under review in Canada, Switzerland and the European Union. Johnson & Johnson, Basilea’s partner, has not issued a release. 

“According to CNN Money, shares of Basilea dropped 25 percent at the news,” Senak writes.