FDA approves Precigen immunotherapy for respiratory papillomatosis

The Food and Drug Administration said it approved Precigen’s (PGEN) Papzimeos, a first-of-its-kind non-replicating adenoviral vector-based immunotherapy for the treatment of adult patients with recurrent respiratory papillomatosis. The disease is associated with significant morbidity, including voice changes, breathing difficulties, and airway obstruction. There are currently no approved medical therapies that eliminate the need for repeated surgical procedures, the FDA said in a statement. “With an estimated 1,000 new cases diagnosed annually in the U.S., RRP represents a rare disease with significant unmet medical need,” it added.