- Halozyme (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.”
- API – Testosterone
- Description– TLANDO® is an oral treatment for testosterone replacement therapy indicated for conditions associated with a deficiency or absence of endogenous testosterone in adult males
- Dosage form: Capsules
Company: Antares Pharma, Inc.
- Warnings and Precautions: -Tlando is associated with the following warnings and precautions: polycythemia, worsening of benign prostatic hyperplasia (BPH) and potential risk of prostate cancer, venous thromboembolism, potential for adverse effects on spermatogenesis, edema, sleep apnea, changes to serum lipid profile, and changes to serum prolactin levels.
- Side Effects -Common adverse reactions include increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, weight increased, headache, and musculoskeletal pain.
- Contraindicated – TLANDO is contraindicated in:
- Patients with carcinoma of the breast or known or suspected carcinoma of the prostate.
- Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman.
- Known hypersensitivity to testosterone undecanoate or any of TLANDO’s ingredients.
- Men with hypogonadal conditions, such as “age-related hypogonadism”, that are not associated with structural or genetic etiologies. The efficacy of TLANDO has not been established for these conditions, and TLANDO can increase BP that can increase the risk of MACE.
“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.”
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 hypogonadism
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® technology with the proprietary enzyme rHuPH20, Halozyme’s commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to patients. Having touched more than 600,000 patient lives in post-marketing use in five commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical.
Halozyme also develops, manufactures and commercializes, for itself or with partners, novel therapeutic products using its advanced auto-injector technology that are designed to provide commercial or functional advantages such as improved safety and efficacy, convenience, improved tolerability, and enhanced patient comfort and adherence. The Company has a commercial portfolio of proprietary products including XYOSTED®, TLANDO™ and NOCDURNA® and partnered commercial products and ongoing product development programs with industry leading pharmaceutical companies including Teva Pharmaceutical, Covis Pharma, Pfizer and Idorsia Pharmaceuticals.
Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility.