Precigen Receives FDA Orphan Drug Exclusivity for Papzimeos

Precigen announced that the FDA has granted orphan drug exclusivity for papzimeos - zopapogene imadenovec-drba - for the treatment of adults with recurrent respiratory papillomatosis, or RRP. Papzimeos was granted full approval by the FDA in August 2025, becoming the first and only approved treatment for adults with RRP, a rare, chronic and debilitating disease. Papzimeos is commercially available in the US and is being prescribed nationwide across both major medical centers and community practices. Orphan drug exclusivity is granted to certain drugs and biologics approved for rare diseases or conditions that affect fewer than 200,000 people in the U.S. The orphan drug exclusivity granted by the FDA for papzimeos for the treatment of adults with RRP is effective through August 14, 2032, providing seven years of market exclusivity in the U.S. RRP is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract that can lead to severe voice disturbance, compromised airways, and recurrent post-obstructive pneumonia.