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FDA set to review testosterone-boosting drug usage

September 16, 2014

Testosterone supplements used last year by about 2.3 million men are spurring debates over how necessary and safe they may be, even as U.S. regulators consider approving a new product.

Food and Drug Administration advisers on Wednesday will consider whether the drugs are being prescribed to the right people. They also will weigh whether the labels should change to reflect heart risks suggested by some studies, according to FDA briefing documents.

The number of men taking testosterone supplements grew by 1 million between 2010 and last year, when AbbVie Inc.’s Androgel, the market leader, generated $1.04 billion in sales. At the same time, 21 percent of patients didn’t have evidence of laboratory testing before taking the supplements, according to an analysis of utilization data that the FDA staff called “particularly concerning” in its briefing document.

Other sellers of testosterone products include Indianapolis-based Eli Lilly and Co., which had $179 million in sales last year for its treatment, called Axiron; and Auxilium Pharmaceuticals Inc., which gained $271 million in 2013 for its Testim gel and Testopel, testosterone pellets implanted under the skin.

“We don’t expect there will be a major change in the labels for these drugs,” said Eric Schmidt, an analyst at Cowen & Co. “But if there were a major negative change to the prescribing materials, you could see a more substantial impact.”

While testosterone replacement therapy has been approved in the United States since 1950 for men with medical conditions leading to deficiencies, such as testicular damage due to chemotherapy, use has surged in men who have low testosterone for no other reason than age, the FDA document said.

The newest product is Rextoro, made by closely-held Clarus Therapeutics Inc. The company is seeking approval for what would be the first oral testosterone medicine in 50 years, according to the drugmaker. The FDA advisers will consider the product on Thursday.

An FDA staff report on Rextoro released Tuesday questioned whether efficacy and safety data provided by Northbrook, Illinois-based Clarus are adequate given the company’s key final-stage trial was missing data on 19 percent of participants after about four months of therapy.

Uncertain conclusions

FDA staff also said they couldn’t draw definitive conclusions on potential cardiovascular risk associated with the drug. The agency is asking the panel to discuss whether more safety studies are needed and whether they should be conducted before or after approval.

“We are looking forward to participating in the FDA Advisory Committee meeting,” said Keri Mattox, a spokeswoman for Auxilium, in an e-mail. “Next steps for the industry will depend upon the outcome of the meeting.”

“It’s premature to speculate on the impact at this juncture,” said Celeste Stanley, an Lilly spokeswoman. AbbVie spokeswoman Libby Holman declined to discuss the possible outcomes of the FDA meeting.

So far, data on the drugs’ cardiovascular effects have been limited and conflicting, the FDA said.

November study

A November study of more than 8,000 men found that testosterone replacement drugs boosted the odds of a heart attack, stroke, or dying by 29 percent. Two other studies, in contrast, found a significant reduction in overall mortality associated with testosterone therapies.

The FDA’s position is “benign” and the agency is unlikely to restrict use, wrote analyst Michael Yee in a Sept. 4 note to clients. Yee said the panel is considering asking drugmakers to run post-marketing cardiovascular studies, which “does seem a bit unreasonable” for smaller biotechnology firms such as Auxilium.

Ultimately, the agency is “unlikely to say something that will completely clear the air here,” Schmidt said. “There may be some overhang in the stock price for a worse case scenario, so we may see a bit of a relief rally if the FDA does nothing.”

Several of the drugmakers, including Lilly, are included in a federal lawsuit in Chicago that claims they hid the risks of using testosterone-replacement drugs.

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