FDA Grants Approval for Hypogonadism Treatment
THURSDAY, March 28, 2019 -- Jatenzo (testosterone undecanoate), an oral testosterone capsule, has been approved to treat men with certain forms of hypogonadism, the U.S. Food and Drug Administration announced Wednesday.
The capsule is indicated for use in men with low testosterone levels due to specific conditions such as Klinefelter syndrome or tumors that have damaged the pituitary gland. Jatenzo is not indicated for men with age-related hypogonadism because the benefits of using the treatment in this indication do not outweigh the risks, according to the FDA.
The approval was based on a four-month efficacy clinical trial of 166 men with hypogonadism. Initially, the men received a 237-mg dose of Jatenzo twice daily. Based on the men's testosterone levels, doses were adjusted down or up to a maximum of 396 mg twice daily. Eighty-seven percent of the treated men reached the primary study end point of an average testosterone level within the normal range.
The boxed warning accompanying Jatenzo indicates that the drug carries the risk for an increase in blood pressure as well as an increased risk for heart attack, stroke, and cardiovascular death. The FDA directs health care providers to consider patients' individual heart disease risks and blood pressure before prescribing Jatenzo. Commonly reported side effects with Jatenzo include headache, increased hematocrit, decreased high-density lipoprotein cholesterol, high blood pressure, nausea, and an increased prostate-specific antigen (PSA) level. Health care providers should monitor patients' blood pressure, hematocrit, cholesterol, and PSA during treatment.
Approval of Jatenzo was granted to Clarus Therapeutics.
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Posted: March 2019