FDA
19th September 2014

FDA Weighs Risk of TRT and Does Not Support Approval of Rextoro

On Wednesday and Thursday, the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee discussed.

FDA Weighs Risk of TRT and Does Not Support Approval of Rextoro

 

On Wednesday and Thursday, the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee discussed the appropriate indicated population for testosterone replacement therapy (TRT) and the potential for adverse cardiovascular outcomes associated with this use. 

There is little evidence that testosterone replacement therapy effectively treats normally declining levels of the hormone in aging American males, a U.S. Food and Drug Administration advisory panel said Wednesday.

The combined panel voted an overwhelmingly, 20-1, to tighten use of the popular drugs and require drug makers to conduct tests assessing the drugs’ risk of heart attack and stroke. The materials from this meeting can be found HERE.

On Thursday, the committees discussed new drug application (NDA) 206089, (oral testosterone undecanoate tablets), submitted by Clarus Therapeutics, for the proposed indication of testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

The panel pointed out there’s no clear scientific evidence showing testosterone replacement can reverse some of the effects of aging, and that there is growing evidence indicating that most men who are receiving testosterone replacement therapy do not actually need it. Only about half of the men now taking testosterone therapy have been diagnosed with hypogonadism (the specific medical diagnosis for testosterone deficiency) as found in an FDA analysis. Furthermore, 25% of men started testosterone therapy without lab testing to confirm that they had low levels of testosterone.

In an 18-3 vote, the panel voted that the overall risk-benefit profile of an oral formulation of testosterone undecanoate did not support approval at this time, citing issues with the pivotal trial, safety, and wide dietary-dependent variations in absorption.

The main results discussed in this meeting where from two phase III pharmacokinetic studies in hypogonadal adult men, whose mean age was about 55 years, with a total serum testosterone of 300 ng/dL or less. For approval of TRT products, the FDA requires a pharmacokinetic study.

A. Michael Lincoff, vice chairman of cardiovascular medicine at the Cleveland Clinic, said some members of the committee were concerned that an oral testosterone product “might tend to be used more off-label”—that is, for lifestyle enhancements such as increased sex drive and energy instead of medical reasons. 

The FDA is not obligated to follow the advice of its advisory committees; however, it normally does so. The materials from this meeting can be found HERE.

 

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

 

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