Marius Pharmaceuticals Receives PDUFA Date for Kyzatrex NDA for Treatment of Hypogonadism
RALEIGH, N.C., March 11, 2021 – Marius Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 31, 2021 for the review of the Kyzatrex® New Drug Application (NDA) for primary and secondary male hypogonadism. Kyzatrex®, an oral testosterone undecanoate softgel, had one of the most comprehensive Phase 3 trials in the testosterone space and if approved, has the potential to be the only first-action approval oral testosterone product on the market. The company plans to launch immediately following product approval.
Hypogonadism, commonly referred to as testosterone deficiency, occurs when the body does not produce sufficient testosterone levels on its own. While testosterone’s role in sexual and reproductive function is widely known, it is also vital to numerous other metabolic and inflammatory processes. In the U.S., there are at least six million symptomatic men suffering from hypogonadism, and over 100 million men globally.
Evidence supports the need for research initiatives to examine hormonal imbalance and the benefits of testosterone therapy in reducing risk factors related to cardiometabolic diseases. Marius also supports broader testosterone testing protocols for those experiencing fatigue, decreased libido, depression, obesity, and Type 2 diabetes. To profess these initiatives, Marius is evaluating expansion of its research program to further explore the positive role of adequate levels of testosterone in the body.
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The resulting medical costs associated with men with untreated hypogonadism and related comorbidities are approximately $25 billion in the U.S. alone. Hypogonadism is also the most common cause of secondary osteoporosis in men and related to a broader set of conditions ranging from Type 2 diabetes to non-alcoholic steatohepatitis, a type of fatty-liver disease.
Kyzatrex® if approved, will represent a novel oral testosterone replacement therapy option for adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
The ReTUNE™ study was a multi-center, 12-month study across the U.S. that studied the safety and efficacy of Kyzatrex® in hypogonadal subjects (total testosterone ≤ 281 ng/dL). Efficacy was determined by number of subjects in the normal, eugonadal range after 90 days of treatment, including dose titrations, while safety was monitored for a further nine months while on a steady dose. In addition to testosterone parameters, the study collected Patient Reported Outcomes (PROs), which showed statistically significant results both from baseline and against its comparator. A pivotal six-month Phase 3 study was conducted, in which subjects were monitored using ABPM, now considered the standard BP assessment by the FDA and clinical experts. An improved dose regimen was also used in the pivotal six-month Phase 3 study. The results of the Phase 3 studies will be published in leading medical journals and presented at national conferences in 2021.
The FDA has conditionally accepted Kyzatrex® as the trade name for this investigational drug. The safety and efficacy have not been fully evaluated by any regulatory authority.
About Marius Pharmaceuticals
Marius is a patient-centric healthcare company focusing on therapies designed for hypogonadism or testosterone deficiency. The company’s mission is to improve the functional lives of patients by reducing the downstream effects of testosterone deficiency which include increased inflammation and fatigue. For more information, please visit www.mariuspharma.com
Source: Marius Pharmaceuticals
Posted: March 2021
- Marius Pharmaceuticals Submits New Drug Application to U.S. FDA for Kyzatrex Next-generation Oral Testosterone Replacement Therapy in Male Patients with Hypogonadism – January 5, 2021
Kyzatrex (testosterone undecanoate) FDA Approval History
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