Over the LABA hurdle

Generally positive comments from FDA reviewers and a panel's overwhelmingly positive vote for olodaterol to treat chronic obstructive pulmonary disorder probably speak less about a change in U.S. regulators' views about LABA safety than they do about the heft of Boehringer Ingelheim GmbH's application.

By designing a robust clinical development program for olodaterol that included multiple studies designed to show a clear dose response, Boehringer sidestepped the problems that caused FDA to send the last long-acting adrenergic receptor beta 2 it reviewed back to the drawing board to establish the lowest effective dose...