The aducanumab review involved everything sponsors might think they could want from the US FDA, with the agency taking a hands on approach to expedite a complex and difficult review in hopes of delivering an important new therapy to patients as quickly as possible. Unfortunately, in this case, FDA seems to have expedited the review right over a cliff.

FDA grants approval to two of three indications for gram-negative antibiotic based on Phase II data but follows its advisors in rejecting a third indication that came without human data, offering hints of what the limitations and possibilities of a formal limited population antibiotic approval pathway might look like.

FDA continues to reshape the antibiotic regulatory pathway, both in word and in deed. The latest example of a collaborative, push-the-envelope review included a novel Actavis antibiotic formulation where FDA seemed ready to approve the drug without any human data. That was one step too far for the agency’s advisors.