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Precigen Receives Orphan Drug Exclusivity for PAPZIMEOS (zopapogene imadenovec-drba) in the United States
Precigen Receives Orphan Drug Exclusivity for PAPZIMEOS (zopapogene imadenovec-drba) in the United States
About this update from Precigen, Inc.
[{"type":"text","content":"FDA grants orphan drug exclusivity for PAPZIMEOS for the treatment of adults with recurrent respiratory papillomatosisSeven-year period of PAPZIMEOS market exclusivity is effective through August 14, 2032PAPZIMEOS, the first and only FDA-approved therapy for adults with recurrent respiratory papillomatosis, is commercially available in the US GERMANTOWN, Md., May 27, 2026 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has granted orphan drug exclusivity for PAPZIMEOS™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (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, with patients spanning a range of disease severities actively receiving treatment.\n \n \n \n \n \n \n \nOrphan drug exclusivity is granted to certain drugs and biologics approved for rare diseases or conditions that affect fewer than 200,000 people in the United States. 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 US from the PAPZIMEOS approval date.\"We appreciate the FDA's recognition of seven years of orphan drug exclusivity for PAPZIMEOS, which is a testament to the groundbreaking pivotal study data and the transformative potential of PAPZIMEOS in addressing the root cause of this rare disease,\" said Helen Sabzevari, PhD, President and CEO of Precigen. \"This regulatory exclusivity, together with Precigen's patent portfolio covering PAPZIMEOS and its therapeutic use, enhances the product's value by strengthening market protection and long-term revenue potential, which in turn supports continued innovation for rare diseases.\"About RRPRRP is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract caused by chronic HPV 6 or HPV 11 infection. RRP can lead to se...