The skinny on endpoints

FDA draft guidance issued last month on clinical development of candidates to treat acute bacterial skin and skin structure infections better reflects clinical practice than the standards that have previously been used for approval. Companies contacted by BioCentury said the guidance provides much needed clarity on the agency's expectations.

Acute bacterial skin and skin structure infections (ABSSSIs) include complicated skin and skin structure infections (cSSSIs). Companies with late stage cSSSI programs said the most significant element of the guidance is the recommended primary endpoint of clinical response at 48-72 hours from the start of treatment...