Commercial launch of TLANDO™ (oral testosterone undecanoate)

madman

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SAN DIEGO, June 7, 2022 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced the commercial launch of TLANDO™ (testosterone undecanoate), an oral treatment indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (primary or hypogonadotropic hypogonadism). TLANDO™ was approved by the U.S. Food and Drug Administration (FDA) on March 28, 2022.

"We are delighted to announce the commercial availability of TLANDO and provide patients with a convenient oral dosing option for testosterone replacement therapy.
The launch of TLANDO represents our second testosterone replacement therapy product, following the 2018 launch of XYOSTED, a weekly subcutaneous auto-injector. The TLANDO approval and commercial launch demonstrate our continued commitment to developing new drug delivery options for patients," commented Dr. Helen Torley, president, and chief executive officer of Halozyme. "We look forward to expanding our market share in this growing therapeutic category with both XYOSTED and TLANDO."

"Our sales organization is well-positioned to leverage its experience and physician relationships established through the commercialization of XYOSTED," said Joe Renda, senior vice president, commercial of Halozyme. "We believe TLANDO's oral formulation and convenient dosing, which requires no titration, are key benefits for physicians and patients."


For full prescribing information, please visit www.TLANDO.com.

About Hypogonadism
Male hypogonadism is an endocrine disorder in which the body fails to produce enough testosterone. Hypogonadism is a common condition in the male population, with a higher prevalence in older men, obese men, and men with type 2 diabetes. It is estimated that approximately 35% of men older than 45 years of age and 30-50% of men with obesity or type 2 diabetes have hypogonadism1. Hypogonadism can be treated with testosterone replacement therapy.

1 Endocrine Society
 



 
 
 

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Estradiol (E2)

A form of estrogen produced from testosterone. Important for bone health, mood, and libido. Too high can cause side effects; too low can affect well-being.

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Dihydrotestosterone is a potent androgen derived from testosterone. Affects hair growth, prostate health, and masculinization effects.

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The biologically active form of testosterone not bound to proteins. Directly available for cellular uptake and biological effects.

Scientific Reference

Lakshman KM, Kaplan B, Travison TG, Basaria S, Knapp PE, Singh AB, LaValley MP, Mazer NA, Bhasin S. The effects of injected testosterone dose and age on the conversion of testosterone to estradiol and dihydrotestosterone in young and older men. J Clin Endocrinol Metab. 2010 Aug;95(8):3955-64.

DOI: 10.1210/jc.2010-0102 | PMID: 20534765 | PMCID: PMC2913038

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