$AGRX After doing some research and reading, I am a little worried. The FDA acknowledges that a previously approved transdermal system (Ortho Evra) and its generic, Xulane, have a limitation of use that states, “ORTHO EVRA may be less effective in preventing pregnancy in women at or above 198 lbs. (90 kg).” This LOU was based on a finding in less than 3% of the trial population. The limited data from the Ortho Evra registration trials conducted almost 20 years ago resulted in the use of the word “may” as opposed to more definitive phrasing. In contrast, the AG200-15 PI in obese subjects is based on more robust data and is more definitive in this regard. The FDA believes that the pre-planned analysis from Study 23 is clinically meaningful and would translate to potentially limiting or restricting use of AG200-15 in roughly a third of women. I am hoping that they reformulate the label and get it passed.
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