Datamonitor proposes that the guidelines for developing obesity therapeutics are going to be overhauled in 2012, with major repercussions for developers. Trial requirements are likely to intensify substantially, the prospect of which has already pushed one developer to suspend US development until clear regulatory pathways are established.
Evolution of cardiovascular risk analysis in diabetes should provide useful blueprints for seismic shifts in obesity risk assessment. Cardiovascular risk assessment requirements will directly impact study populations, trial size and duration of study, while the very purpose of obesity therapies may ultimately be revisited and redefined.
The FDA is likely to provide companies mid-regulatory review with a degree of flexibility. Datamonitor believes that this may not improve their candidates’ long term prospects, but might explain their eagerness to resubmit their new drug applications beyond obvious and conventional commercial competitiveness.
Diabetes will not provide all the answers for obesity risk/benefit analysis, but it does provide a starting point. Likely frameworks will dramatically increase future development costs, but by the same token, these standards provide a far clearer picture of acceptable risk benefit profiles - capable of attracting developers in the longer term.