Put a lid on 'Low-T' drug use, FDA panel advises, threatening AbbVie, Lilly meds

The testosterone-drug party may be over. An FDA advisory panel wants to limit their use for safety reasons--and the proposed restrictions would shrink sales significantly. That's not good news for AbbVie ($ABBV), the market leader, and other drugmakers that have been riding a surge of testosterone growth.

After sifting the data on cardiovascular risks at a meeting Wednesday, FDA's expert advisers voted 14-1 to restrict testosterone-replacement therapies to men with a related medical condition, such as a tumor or a genetic disorder. Right now, the drugs are approved for men with clinically low testosterone levels, based on blood tests.

Testosterone drug sales took off a couple of years ago, as AbbVie--then part of Abbott Laboratories ($ABT)--Eli Lilly ($LLY) and other drugmakers extolled their virtues in expensive ad campaigns. The market researchers at Decision Resources predicted that the market would grow to $5 billion by 2017.

AbbVie's AndroGel itself grew to $1.15 billion in 2012. But that's when the safety questions started multiplying. Early last year, Consumer Reports urged men to be wary about starting hormone therapy, saying most really don't need the drugs. The magazine cited drugmakers' big-time spending on marketing the products, with promotional expenses up to $100 million in 2012 from $14 million in 2011.

By November, a Journal of the American Medical Association study had found increases in rates of heart attack, death and stroke among testosterone users, compared with those who didn't use the drugs. And as an accompanying editorial pointed out, some men were using testosterone for lifestyle reasons, rather than to replace actual, clinical deficits in their hormone levels--for antiaging and "physical enhancement," for instance, JAMA notes.

Meanwhile, AbbVie's AndroGel sales were flagging slightly, dropping by 10% in 2013 to just over $1 billion. A rival drug from Auxilium ($AUXL), Testim, saw sales suffer so much that the company is now planning to lay off 30% of its workforce.

Critics pounced on the JAMA study. A separate analysis of Medicare patients records concluded that the drugs not only didn't increase the risk of heart attack, but might protect against one in men at highest risk. Meanwhile, the FDA and its counterparts in Europe were reviewing the latest data on their safety.

The advisory panel convened to look at the issue, and obviously agreed with those worried about widespread use of testosterone replacements. In addition to the proposed limitations, the committee also voted in favor of new cardiovascular-safety studies in men with age-related low testosterone.

Regulatory limits aren't the only worries for these drugmakers, either. A panel of judges in Chicago recently consolidated a number of mounting cases against Abbott and AbbVie, which sell AndroGel; Eli Lilly, which makes the armpit swipe Axiron; Pfizer ($PFE), for its injectable version; and Actavis ($ACT) for its testosterone patch.

- read the Reuters news

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