The U.S. Food and Drug Administration (FDA) has approved Papzimeos (zopapogene imadenovec-drba), developed by Precigen, Inc., for the treatment of adult patients with recurrent respiratory papillomatosis (RRP). This marks the first approval of a non-replicating adenoviral vector-based immunotherapy for this rare and chronic condition.
Drug Mechanism
Papzimeos is administered via subcutaneous injection and is designed to stimulate an immune response against cells infected with human papillomavirus (HPV) types 6 and 11. This novel mechanism of action differentiates it from traditional treatments, which have primarily relied on repeated surgical interventions.
RRP Background
RRP is caused by persistent HPV 6 or 11 infection, leading to the growth of benign tumors in the respiratory tract, most commonly in the larynx. The disease is associated with significant morbidity, including voice changes, breathing difficulties, and airway obstruction. Currently, there are no approved medical therapies that eliminate the need for repeated surgical procedures, making this approval particularly impactful for patients.-Fineline Info & Tech
