Endo Aveed’s Safety Problems Weigh On Cmte., But Hope For Narrower Population Tips Scale For Some
This article was originally published in The Pink Sheet Daily
FDA’s Reproductive Health Drugs and Risk Management advisory committees split on whether the safety of Endo’s injectable testosterone Aveed is safe for the proposed indication, with many on both sides seeing value in the drug for patients who “have to take testosterone.”
You may also be interested in...
Formerly of Valeant, new CEO Rajiv De Silva appears to be reworking Endo in the mold of his previous company, with plans to divest its early-stage pipeline and focus on growth through business development.
Without predictive factors to determine who is likely to get a severe post-injection reaction, FDA advisory committees say Endo’s proposed REMS for its long-acting testosterone is unlikely to allay safety concerns.
FDA briefing documents for the advisory committee review of Endo’s Aveed cite the “excessive burden” imposed by any one of the REMS restrictive elements, given the injectable testosterone’s limited additional benefit compared to other available treatment options.