First FDA-Approved Treatment for Adults With Recurrent Respiratory Papillomatosis

Papzimeos (zopapogene imadenovec-drba) is a non-replicating adenoviral vector-based immunotherapy given by subcutaneous injection. On the US Prescribing Information (DailyMed / revised 8/2025) it is indicated for the treatment of adults with recurrent respiratory papillomatosis.

This is a traditional/full FDA biologic approval (CBER). The FDA approved STN BL 125832 on 14 August 2025. Precigen materials describe traditional full approval without a required confirmatory trial. U.S. License 2364. Marketing start on labelling repositories about 15 September 2025.

Distinct path — not this carton (fact-only): Repeated surgical debulking alone is not this immunotherapy carton. Systemic bevacizumab or other off-label RRP regimens are separate clinician conversations — not this labelled four-dose subcutaneous door. Pediatric RRP is not established on this label. Today’s US labelled immunotherapy door for adults with RRP is Precigen Papzimeos STN 125832.

Manufactured by Precigen, Inc., Germantown, MD (U.S. License 2364).

Where this is taking place

Commercial labelled door today: United States — FDA-labelled Papzimeos for adults with RRP, prescribed through an ENT / laryngology / complex-airway clinician who can plan surgical debulking to minimal residual disease, schedule four subcutaneous doses over 12 weeks, monitor injection-site reactions (at least 30 minutes after the first dose), and arrange specialty pharmacy / Papzimeos SUPPORT logistics. Company patient-support line on HCP materials: Papzimeos SUPPORT 1-866-827-8180 (Mon–Fri 8 a.m.–8 p.m. ET). This is a prescription specialty-product conversation with planned OR/clinic debulking — not a DIY import.

Outside the United States: As of this draft, no confirmed Health Canada Notice of Compliance, European Commission marketing authorisation, MHRA licence, TGA listing, Swissmedic authorisation, or PMDA/MHLW licence for Papzimeos. Do not import on your own.

PRGN-2012-201 — NCT04724980 (ClinicalTrials.gov: ACTIVE_NOT_RECRUITING) — Open-label Phase 1/2 pivotal study in adults with RRP who had ≥3 laryngotracheal debulking procedures in the prior 12 months. Lead sponsor framing: Precigen. Efficacy population at the labelled 5×10¹¹ PU dose: 35 adults. Honesty: Labelled commercial access is through US clinicians and SUPPORT — the pivotal cohort is not open commercial trial enrolment.

The practical commercial door in the US is an ENT / laryngology clinician who manages RRP surgeries, can coordinate debulking timing with the four-dose schedule, and can enrol benefits investigation through Papzimeos SUPPORT if needed.

Approval matrix

Access by country

• United States: Ask an ENT / laryngology clinician about FDA-labelled Papzimeos. Labelled 14 August 2025 for adults with RRP. Path: surgical debulking to minimal residual disease → 5×10¹¹ PU SC on the Days 1 / ~15 / ~43 / ~85 schedule → repeat debulking before doses 3 and 4 if visible papilloma remains → watch injection sites and clotting symptoms. Carton NDC 84768-511-01 (single-dose vial 84768-511-99). Store frozen ≤ −60 °C; thaw rapidly; do not hold at room temperature >60 minutes after thaw. Suspected adverse reactions: Precigen 1-855-743-6777 / medinfo@precigen.com or FDA MedWatch 1-800-FDA-1088. Patient / benefits navigation: Papzimeos SUPPORT 1-866-827-8180. No list price or copay dollars in this article. This is US labelled commercial supply, not a DIY import.

• Canada: Papzimeos authorisation not confirmed. Ask the Canadian airway / ENT clinic what legal paths exist in Canada when a Canadian Papzimeos label does not yet exist.

• European Union / United Kingdom / Australia / Japan / other countries: Regulator authorisation not confirmed in this draft. Do not import on your own.

• If your regulator has not authorised it: do not import on your own. Ask the local clinician about documented special-access / named-patient rules, referral to a centre in a labelled country, or waiting.

Who is eligible (from the US label)

This is an adult RRP immunotherapy conversation on the Prescribing Information — not a paediatric carton, and not a replacement for urgently needed airway surgery.

United States (USPI):

• Indication: Treatment of adults with recurrent respiratory papillomatosis.
• Recommended dosage: 5×10¹¹ PU per subcutaneous injection four times over a 12-week interval (initial; second ≥11 days later / about 2 weeks; third about 6 weeks; fourth about 12 weeks).
• Surgical debulking: Required before the first dose to establish minimal residual disease; remove visible papilloma before the third and fourth doses if present.
• Contraindications: None.
• Warnings: Injection-site reactions (monitor ≥30 minutes after first dose); thrombotic events — monitor and treat per clinical practice.
• Most common adverse reactions (≥5%): injection-site reaction (97%), fatigue (74%), chills (66%), pyrexia (63%), myalgia (29%), nausea (26%), headache (11%), tachycardia (8%), diarrhea / vomiting / hyperhidrosis (5% each). No Grade >2 ARs in the pivotal safety set (N=38).
• Pediatrics: Safety and effectiveness not established.
• Trial entry context (pivotal): Adults with ≥3 debulking procedures in the prior 12 months (including protocol Day-1 surgery).

Not labelled on sources confirmed for this draft:

• Children / adolescents with RRP.
• Canadian, EU, UK, Japanese, Australian, or Swiss Papzimeos marketing authorisations (not confirmed here).
• Treating NCT04724980 as open commercial trial recruitment.

What the pivotal study showed (USPI)

Use the USPI for a prescription conversation. Journals are supportive reading.

PRGN-2012-201 — NCT04724980:

• Open-label; adults with RRP and ≥3 laryngotracheal debulking procedures in the prior year.
• Labelled-dose efficacy population: 35 patients at 5×10¹¹ PU per injection ×4.
• Primary endpoint framing: complete response = no surgical intervention needed in the 12 months after treatment.
• 18/35 (51%;** 95% CI 34–69%) complete response at 12 months.
• 15/35 (43%;** 95% CI 26–61%) still complete response at 24 months.
• Median prior surgeries in the baseline year: 4 (range 3–10), including Day-1 debulking.
• Dose 1×10¹¹ PU (n=3): 0/3 complete responses — not the labelled dose.

How to talk with a doctor

Bring this page and ask an ENT / laryngology clinician:

1. “I am an adult with RRP and repeated airway surgeries. Does labelled US Papzimeos fit after debulking?”
2. “How would you schedule the four subcutaneous doses around the OR dates for doses 1, 3, and 4?”
3. “What injection-site and clotting-symptom watch should I use after each shot?”
4. “Can your office start Papzimeos SUPPORT benefits investigation with me?”
5. If outside the US: “Has our regulator authorised Papzimeos, or what legal special-access options exist?”

Who is involved (from primary sources)

• Sponsor / manufacturer: Precigen, Inc., Germantown, MD — U.S. License 2364 (USPI).
• Pivotal trial: PRGN-2012-201 (NCT04724980).
• AE contact (USPI): Precigen 1-855-743-6777 / medinfo@precigen.com.
• Patient support (company HCP materials): Papzimeos SUPPORT 1-866-827-8180 (Mon–Fri 8 a.m.–8 p.m. ET).

Names and roles above are limited to what appears on the primary sources cited. Contacts not listed on those sources are omitted.

Sources

• FDA Papzimeos product page / approval letter 14 Aug 2025 (STN BL 125832)
• DailyMed / USPI Papzimeos (zopapogene imadenovec-drba), revised 8/2025
• ClinicalTrials.gov NCT04724980
• Precigen Papzimeos HCP dosing / SUPPORT materials

Authorized is not funded. Not medical advice.