FDA approves Jatenzo for some forms of hypogonadism

The US Food and Drug Administration on Wednesday approved Jatenzo (testosterone undecanoate), an oral testosterone capsule intended for the treatment of men with certain forms of hypogonadism developed by the privately owned Clarus Therapeutics.

These men have low testosterone levels because of specific medical conditions, such as genetic disorders such as Klinefelter syndrome or tumors that have damaged the pituitary gland. Jatenzo should not be used in men with "age-related hypogonadism," in which testosterone levels decline as a result of aging, even though these men have symptoms that appear to be related to low testosterone levels . The benefits of Jatenzo do not outweigh the risks badociated with this use, says the FDA statement.

Jatenzo is the first exclusive oral formulation of softgel, and the first oral testosterone-based drug approved for more than 60 years. The FDA's approval is based on data from Phase III clinical trials in vivo, which showed that 87% of hypogonadal men treated with Jatenzo achieved normal daily average testosterone levels, with a generally consistent adverse events profile. other alternative treatments of T.

Following a previous full response letter (CRL) sent to Clarus by the FDA, the company re-submitted its New Drug Application (NDA) in June 2017 and responded to all questions raised by the agency.

Important addition to current treatment

"The oral route of Jatenzo administration is an important addition to the current treatment options available to men with certain hypogonadias who, until now, were most often treated with applied testosterone products." on the skin or injected, "said Dr. Hylton Joffe, director of bone products division, reproduction and urology at the FDA's Drug Evaluation and Research Center. "But it is important to point out that this drug should not, like other testosterone treatments, be used in older men with" age-related hypogonadism. "The benefits of treatment with Testosterone, including Jatenzo, have not been established for this use, The effects on the elevation of blood pressure may increase the risk of heart attack, stroke and cardiovascular death in this population, "he added.

"Oral Jatenzo's approval represents a significant new treatment option for men with hypogonadia," said Dr. Robert Dudley, President and CEO of Clarus, adding, "We are confident that a Oral replacement testosterone therapy could offer appropriate adult patients and their physicians the opportunity to reconsider treatment options and to help hypogonadal men find relief for their symptoms. "

Jatenzo contains on its label a warning stating that the drug may cause an increase in blood pressure, which increases the risk of heart attack, stroke and cardiovascular death. Healthcare providers should consider the patient's risk of heart disease and ensure that blood pressure is properly controlled before prescribing Jatenzo. they should also periodically monitor the patient's blood pressure during treatment. Jatenzo is currently one of two testosterone-based products for which this warning is boxed. The FDA is asking all manufacturers of testosterone products to conduct post-marketing blood pressure testing to determine more clearly whether these products increase blood pressure.