- GBI & PARTNERS
- Visen's long-acting growth hormone under US marketing review
Visen's long-acting growth hormone under US marketing review
Denmark-based Ascendis Pharma A/S (Nasdaq:ASND) submitted an NDA for its novel long-acting growth hormone (LAGH) therapy TransCon, a human growth hormone (HGH) for use in childhood growth hormone deficiency (GHD), with the US FDA. Visen is a joint venture (JV) between Ascendis and China’s Vivo Capital, and holds exclusive rights to Ascendis's endocrine therapy in mainland China, Hong Kong, Taiwan, and Macau.
TransCon is the world’s only HGH prodrug developed through Ascendis’ proprietary Transient Conjugation technology. It releases unmodified and active HGH in vivo for seven days, and distribution is consistent with its once-daily recombinant (rHGH) counterpart. No long-acting growth hormone is available in the US or EU. TransCon earned EU orphan status for GHD in October 2019, and was later nodded for a Phase III clinical study in pediatric GHD by China’s National Medical Products Administration (NMPA). In April 2020, it earned Orphan Drug Designation (ODD) from the US FDA.