Clarus Therapeutics gets USFDA nod to Jatenzo for treatment of hypogonadism

The efficacy of Jatenzo was demonstrated in a four-month clinical trial involving 166 men with hypogonadism.

New Delhi: The U.S. Food and Drug Administration recently approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism.

The drug is indicated for men with low testosterone levels due to specific medical conditions, such as genetic disorders like Klinefelter syndrome or tumours that have damaged the pituitary gland.

Commenting on the approval, Hylton V. Joffe, M.D, M.M.Sc., director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research said, “Jatenzo’s oral route of administration provides an important addition to current treatment options available for men with certain hypogonadal conditions who up until now have most commonly been treated with testosterone products that are applied to the skin or injected.”

According to FDA, Jatenzo should not be used to treat men with “age-related hypogonadism,” in which testosterone levels decline due to ageing, even if these men have symptoms that appear to be related to low testosterone. Jatenzo’s benefits do not outweigh its risks for that use.

“But it’s important to emphasize that this drug should not, like other testosterone treatments, be used to treat older men with ‘age-related hypogonadism.’ The benefits of testosterone therapy, including Jatenzo, have not been established for this use, and Jatenzo’s effects on raising blood pressure can increase the risks of heart attack, stroke and cardiovascular death in this population,” said Joffe.

The efficacy of Jatenzo was demonstrated in a four-month clinical trial involving 166 men with hypogonadism. Study participants initially were given Jatenzo at a dose of 237 mg twice per day, and the dose was adjusted downward or upward to a maximum of 396 mg twice per day on the basis of testosterone levels. Eighty-seven per cent of Jatenzo-treated men achieved an average testosterone level within the normal range, which was the primary study endpoint.

Common side effects, occurring in more than 2 per cent of patients in the Jatenzo clinical trial, included headache, an increase in hematocrit (red blood cell count), a decrease in high-density lipoprotein cholesterol (“good” cholesterol), high blood pressure and nausea. An increase in prostate-specific antigen (PSA) was also observed. Patients should have their hematocrit, cholesterol and PSA monitored regularly to check for changes. Those with benign prostate hyperplasia should be monitored for worsening of symptoms.

Jatenzo contains a boxed warning on its labelling stating that the drug can cause blood pressure to rise, increasing the risk of heart attack, stroke and cardiovascular death.

"Health care providers should consider a patient’s individual heart disease risks and ensure that blood pressure is adequately controlled before prescribing Jatenzo; they should also periodically monitor patient blood pressure during treatment," said FDA officials.

Jatenzo is currently one of two testosterone products that have this boxed warning. The FDA is requiring all testosterone product manufacturers to conduct blood pressure postmarketing trials to more clearly address whether these products increase blood pressure.

The FDA granted the approval of Jatenzo to Clarus Therapeutics.

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