Monday, April 9, 2012
FDA may be on the verge of approving the first new obesity
drug in more than a decade - Qnexa phentermine/topiramate from Vivus
Inc. But it could be another five to six years before next-generation
compounds are available, if FDA adopts an advisory panel's recommendation that
new treatments undergo lengthy cardiovascular assessment prior to approval.
Most next-generation programs
are in Phase II or earlier, and companies told BioCentury the recommendation
could add two years to Phase III trials. It typically takes three or four years
to run Phase III obesity studies and submit an NDA, meaning it could be another
five or six years before agents now in Phase II are under review.