Endo’s Aveed and the State of REMS After Five Years
This article was originally published in RPM Report
The REMS era is five years old – almost as old as the original NDA filing for Endo’s long-acting testosterone injection Aveed. A recent FDA advisory committee review of that application (now on its third cycle) captures many of the current themes in REMS policy.
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FDA’s use of REMS continues to fall to almost undetectable levels, with the agency using the safety tools just a handful of times in the sixth full year of the program. REMS are now very much the exception and not the rule for new products – but still a very important exception.
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’s advisory committee members seem to be adopting the new post-marketing REMS authority with more enthusiasm than FDA’s own staff. Many of the advisory committee members – especially people who have served on the Drug Safety & Risk Management Advisory Committee – are jumping at the middle ground solution (between approval and rejection) offered by REMS. The Avandia re-review on July 13-14 demonstrated the strong appeal of REMS in a tough regulatory situation.