US FDA’s Higher Bar For Postmarketing Pregnancy Studies Shown By AMAG’s Vyleesi, Sprout’s Addyi
Agency’s postmarketing requirements to assess Vyleesi risk in pregnant and lactating women highlight the changes catalyzed by draft guidances issued in April.
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AMAG Pharmaceutical’s HSDD drug Vyleesi, has been approved by the FDA. But analysts warn it must build the market in women who may not be aware they have a condition if it is to fare better than Sprout’s Addyi.
Draft guidance recommends complementary studies to evaluate effects of drug use during pregnancy; FDA may require lactation studies more frequently.
Pregnant Women In Clinical Trials: US FDA Lays Out Different Considerations For Premarket, Postmarket
Draft guidance emphasizes postmarket consideration of other data, while advice on premarket trials suggests weighing 'prospect of direct benefit to the pregnant woman and/or fetus.'