Denmark-based Ascendis Pharma A/S (NASDAQ: ASND) has announced that the US Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for TransCon hGH (lonapegsomatropin-tcgd) for the treatment of adult growth hormone deficiency (GHD). The FDA’s decision is anticipated by the Prescription Drug User Fee Act (PDUFA) target date of July 27, 2025.
Visen Pharmaceuticals Holds Exclusive Rights in Greater China
Visen Pharmaceuticals, a joint venture between Ascendis Pharma and Vivo Capital, a Chinese healthcare-focused investment firm, possesses exclusive rights to develop, manufacture, and commercialize lonapegsomatropin in Greater China. This human growth hormone prodrug is designed using the innovative TransCon (Temporary Connection) technology platform, which is a patented technology recognized as a world leader in its field.
Mechanism of Action and Safety Profile
The mechanism of action of lonapegsomatropin differs from other long-acting growth hormone analogues due to its technology. After weekly administration, it can slowly release unmodified human growth hormone in a controlled manner within the body. The released growth hormone is structurally identical to the endogenous growth hormone produced by the human body, and it shares the same biological activity, mechanism of action, and physiological distribution as widely used daily growth hormone preparations. This ensures the safety and effectiveness of lonapegsomatropin. The drug has already received FDA approval and European Commission (EC) authorization for pediatric growth hormone deficiency in August 2021 and January 2022, respectively.-Fineline Info & Tech
