The European Medicines Agency (EMA) has thrown more cold water on sales of testosterone-raising meds as a party drug for aging men. The agency said today that the evidence is inconsistent about the cardio risks of the drugs, but they should only be reserved to treat men whose level is low because of a medical condition.
"Testosterone levels naturally fall somewhat with age, but restoration of these levels in healthy older men is not an authorized use of the medicine in the EU," an EMA oversight committee said today.
It is pretty much the same conclusion reached by an FDA committee of experts which in September voted 14-1 to recommend the FDA restrict testosterone-replacement therapies to men with a related medical condition, such as a tumor or a genetic disorder. Currently the drugs are approved for men with clinically low testosterone levels, based on blood tests.
The moves can be expected to further dampen sales of drugs like Androgel, the market leader from AbbVie ($ABBV), and drugs from Eli Lilly ($LLY) and Pfizer ($PFE), whose products have helped grow the market by 90% in 5 years to reach $1.9 billion in 2011. Direct to consumer advertising for "Low T" have led many men to supplement falling testosterone counts with the products to boost their sex drive, improve mood and strengthen muscle tone.
But questions about safety have already turned the tide on growth in the category. Androgel, maintained its blockbuster status last year with sales of $1 billion, but that was off 10% from $1.15 billion in 2012. Auxilium, ($AUXL) has had to cut about 30% of its workforce because sales of its Testim have suffered in the midst of the safety debate. Adding to the woes has been a spate of lawsuits by men who suffered heart problems and said the risks were not spelled out by drugmakers.
As the EMA noted, the data on heart risks has been inconsistent. It jumped into the issue earlier this year because of "some recent studies suggesting an increase in heart problems in men using testosterone, compared with men not using it." A study in the Journal of the American Medical Association last year found increased rates of heart attack, death and stroke among testosterone users, but then one relying on Medicare data contradicted that.
So the EMA says what it intends to do is have drugmakers put warnings on labels about those who might be at increased risk of heart problems. It said the labels should also point out that low levels should be confirmed by lab tests, and that treating naturally low levels "in healthy older men is not an authorized use."
- here's the EMA release