FDA Approves Recurrent Respiratory Papillomatosis Treatment, Papzimeos

Precigen announced today the FDA approval of Papzimeos (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP), according to a news release. This is the first and only FDA-approved therapy for adults with RRP. A confirmatory clinical trial is not needed. Precigen will hold a conference call on August 18 at 8:00 am ET to provide additional details.

RRP is a rare and potentially life-threatening disease characterized by the growth of benign, wart-like growths called papilloma on the upper and lower respiratory tract, caused by specific types of human papillomavirus (HPV), specifically HPV 6 or HPV 11.

Approximately 27,000 adults in the United States suffer from RRP. Symptoms include hoarseness, chronic cough or breathing problems. It is typically managed through surgery. Procedure frequency depends on the individual, with some patients requiring removal every few weeks to every few years. Patients with severe cases may need a trach tube placed indefinitely due to breathing problems. Although there is no cure for RRP once it develops, the HPV vaccine may prevent it.

"This long-awaited FDA approval represents a momentous milestone for the RRP community," Kim McClellan, president of the Recurrent Respiratory Papillomatosis Foundation, said in the news release. “This breakthrough brings long-overdue hope to patients and families who have endured so much.”

Papzimeos is a non-replicating adenoviral vector-based subcutaneous immunotherapy injection that targets HPV 6 and HPV 11. The recommended dose is 5x10¹¹ particle units per injection given four times over 12 weeks, according to the prescribing information. Papzimeos comes as a frozen single-dose vial and must be thawed for immediate administration. A surgical debulking of the affected area is recommended before receiving the initial injection.

This approval is based on the results of Study PRGN-2012-201, in which 51% (18 out of 35) of patients treated with Papzimeos achieved a complete response of requiring no surgeries for over 12 months. An ongoing study of 15 patients showed a continued complete response at 24 months.

The safety of Papzimeos was also determined in Study PRGN-2012-201. Out of 38 patients, the most common adverse reactions were injection site reaction (97%), fatigue (74%) and chills (66%).

"For more than a century, since RRP was first recognized as a distinct disease, patients have had to rely on repeated surgeries to manage this relentless condition," Helen Sabzevari, Ph.D., president and CEO of Precigen, said in the news release. “Today marks a historic turning point. With the landmark FDA approval of Papzimeos and the broad label, all adult RRP patients are now eligible for access to the first and only approved therapy that targets the root cause of the disease.”

Patients in need of insurance navigation help or financial assistance can call Papzimeos SUPPORT, which can be accessed at 866-827-8180.