Solvay submits US sNDA for AndroGel

The US unit of Belgian drugmaker Solvay has submitted a supplemental New Drug Application for AndroGel (testosterone gel) 1% to the Food and Drug Administration for treatment in male adolescents aged 13-17 years with primary or secondary hypogonadism. Solvay is also seeking an additional indication for AndroGel in the treatment of constitutional delay in growth and puberty (CDGP) in male adolescents.

The firm proposes to market the product under the trade name AndroGel PD for these two indications. As part of the application for the new uses, the company has requested a review for pediatric exclusivity designation. If granted, this would extend the AndroGel patent by six months.

The sNDA submission is based on two studies that evaluated AndroGel in more than 80 male adolescents with hypogonadism and CDGP for up to six months. The once-daily, clear, odorless topical testosterone gel was approved by the FDA in 2000 for replacement therapy in men aged 18 and older for conditions associated with a deficiency or absence of endogenous testosterone. Solvay noted that over 32,000 male teenagers may require testosterone therapy to initiate puberty. Combined with Klinefelter's syndrome alone, the potential CDGP market for AndroGel exceeds 50,000 adolescent males.