MORRISVILLE, N.C. -- (BUSINESS WIRE) -- SOV Therapeutics Inc. today announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for the use of oral testosterone undecanoate, a pro-drug of testosterone, in the treatment of Constitutional Delay of Growth and Puberty (CDGP) in adolescent boys (14-17 years of age).
The US Orphan Drug Designation program provides orphan status to drugs intended to treat rare diseases or disorders that affect fewer than 200,000 people in the US. Orphan designation by the FDA qualifies the sponsor for incentives provided for in the Orphan Drug Act, which can include design support for clinical trials, fee waivers, tax incentives, eligibility for expedited review, and seven years of market exclusivity upon approval.
SOV Therapeutics, Inc. a privately held biotechnology company, is developing orally bioavailable formulations of testosterone undecanoate, a pro-drug of testosterone, as the basis for testosterone replacement therapy in the treatment of adult male and adolescent hypogonadism. There are approximately 100,000 adolescent boys (14-17 years of age) with CDGP in the US.
“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,” said Dr Om Dhingra, President and Chief Executive Officer of SOV Therapeutics. “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,” said Dr Alan Rogol, Professor Emeritus of Pediatric Endocrinology at the University of Virginia Medical Center and an advisor to SOV Therapeutics.
About CDGP: CDGP is suspected in boys who do not begin secondary sexual development or growth spurt by age 14 years. Without treatment, CDGP adolescent males 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.