Deconstructing iloperidone

FDAhas added schizophrenia to the list of diseases and conditions for which the agency believes it is unsafe to market a drug that has low efficacy, making efficacy an intrinsic part of safety. That’s the take-home message from the agency’s recent not approvable letter to Vanda Pharmaceuticals Inc. for iloperidone.

Last week, FDA officials told BioCentury the not-approvable decision makes it clear for the first time that in the absence of other benefits, a compound that is less efficacious than approved drugs won’t be approved for schizophrenia...