Antibacterial Therapy Guidance Comments

Genentech says it is happy to see an FDA flexible approach to meeting the requirements for substantial evidence of effectiveness when faced with clinical trial challenges and the potential need for concomitant antibacterial drug therapy. The company commented on an FDA draft guidance Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases—Questions and Answers (Revision 1). Genentech also lists portions of the guidance that it says could benefit from more clarity and from examples on overlapping combination therapy of more than one active agent. It also calls for a broadening of the scope of requirements involving active comparators.

In its letter, GlaxoSmithKline says there seems to be a focus and emphasis in the guidance through the examples used for hospital-treated serious infections. It recommends adding examples of community infections that would also be considered. It also gives specific line-by-line comments.