The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to SOV Therapeutics' oral testosterone undecanoate, a pro-drug of testosterone, for the treatment of Constitutional Delay of Growth and Puberty (CDGP) in adolescent boys (14-17 years of age).
Rare disease CDGP, if not treated, in adolescent boys may fail to reach full genetic height potential, experience adverse effects on skeletal proportions and bone mass, and delayed sexual and psychosocial integration into society, according to the company.
University of Virginia Medical Center Emeritus of Pediatric Endocrinology professor Alan Rogol said, "Current treatment options for these conditions are limited and we believe that the availability of an oral form of testosterone replacement therapy could offer significant advantages for patients and their families."
SOV Therapeutics president and chief executive officer Om Dhingra said, "Receiving Orphan Drug Designation by the FDA is an important milestone for SOV Therapeutics, as well as for adolescent boys with CDGP and we look forward to advancing our unique formulation into clinical trials in this patient population."
Approximately 100,000 adolescent boys (14-17 years of age) are suffering from CDGP in the US.
