EVER Pharma, a fully integrated specialty pharmaceuticals company, has announced the approval of Testosterone Undecanoate in the European Union for the treatment of male hypogonadism. This therapy, an intramuscular injection with a unique depot formulation, has been shown to effectively treat the symptoms of hypogonadism in men with confirmed testosterone deficiency1.

Male hypogonadism is a condition characterized by low testosterone levels and a range of associated symptoms, affecting up to 10% of men globally and 40% of men aged 452. Testosterone Undecanoate is a long-acting injectable testosterone used in androgen replacement therapy in men. The therapy has been shown to improve symptoms such as decreased lean muscle mass, fatigue, and low libido2.

“Male hypogonadism can have a significant impact on a person’s quality of life, and it is important to have effective treatment options available. We are pleased to provide increased access for patients to this important therapy,” said Georges Kahwati, General Manager of EVER Pharma.

The approval of Testosterone Undecanoate demonstrates EVER Pharma’s commitment to providing essential pharmaceuticals globally and its expertise in developing and manufacturing complex therapies, including long-acting hormones. EVER Testosterone Undecanoate is planned for global rollout.

1Testosterone Undecanoate EVER Pharma is indicated for testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.
2Campbell K., Muthigi A., Ghomeshi A., Schuppe K., Sandler M. D., & Ramasamy R. (2023). Safety Aspects and Rational Use of Testosterone Undecanoate in the Treatment of Testosterone Deficiency: Clinical Insights. Drug Healthc Patient Safety, 15, 73-84.