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FDA approves marketing of generic version testosterone gel

The FDA on Thursday approved marketing of a generic version of testosterone gel 1.62% as replacement therapy for men with hypogonadism, according to a press release from Lupin.

Testosterone gel 1.62% (20.25 mg/1.25 g pump actuation) is the generic equivalent of AbbVie’s AndroGel, 1.62%, first approved by the FDA in 2011. It is indicated for replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone, including congenital or acquired primary hypogonadism and congenital or acquired hypogonadotropic hypogonadism, according to the release.

NEW ORLEANS — Long-term testosterone therapy may not only help men with obesity and hypogonadism to lose weight, but it may have other useful effects on metabolic function and protect against obesity comorbidities, according to a presentation at the Androgen Society annual meeting.

“Going forward, we will see many more clinics that will be adopting to add testosterone therapy in addition to lifestyle modification for men who are obese and hypogonadal,” Abdulmaged M. Traish, PhD, professor of biochemistry and urology at Boston University School of Medicine, told Endocrine Today. “It’s not a light switch. It takes time. It takes several years to begin to see a considerable and consistent weight loss. If you ever want to remodel your kitchen, you cannot do it overnight. The same thing in biology. You don’t lose weight because all these fat cells are going to die overnight, and all these muscle cells are going to grow up overnight. It takes a gradual process.”

Traish presented the findings of a prospective registry study of 805 men with hypogonadism (mean age, 59 years) and their responses to testosterone therapy in relation to obesity and other metabolic measures. Weight status was varied in the total cohort, with 462 men with obesity, 280 with overweight and 63 with normal weight. A total of 412 men, including 273 with obesity, were treated with testosterone undecanoate injections at 12-week intervals for 10 years. The other 393 participants elected to go untreated and served as a control comparison for the treatment group.

After treatment, the researchers found that there was a noticeable decrease in the percentage of weight loss from baseline, especially after 2 years, in participants with overweight (P < .0001 after 2 years) and obesity (P < .01 through 2 years; P < .0001 for years 2 to 10) compared with those who went untreated. Testosterone therapy was associated with reduced mean body weight from 97.3 kg to 84.6 kg in the cohort with decreases in waist circumference (107 cm to 92 cm) and BMI (31 kg/m2 to 27 kg/m2). In addition, testosterone therapy led to improved HbA1c, blood glucose, total cholesterol and visceral fat levels, according to Traish, who said because the study included a control group and accurate adherence since the testosterone injections were made by a physician every 3 months, “this data is really significant and important.”

The researchers also monitored adverse events in the cohort and found that there were 12 deaths, but no myocardial infarctions or strokes in the men with obesity treated with testosterone compared with 57 deaths, 47 MIs and 44 strokes in men who were untreated. The rates of prostate cancer were 2.9% (n = 8) in the men with obesity who were treated with testosterone and 11.1% (n = 21) in the men with obesity who were untreated (P < .0005), although Traish said he found slight but expected increases in hemoglobin and hematocrit in those treated with testosterone.

Traish A, et al. Should testosterone therapy be offered to treat obesity. Presented at: The Androgen Society 2nd Annual Meeting; March 21-22, 2019; New Orleans.