Inovio Wins FDA Accelerated Approval For Voceryq, Its First Product, After 7 Of 26 Patients Needed No Surgery
The DNA-based RRP therapy cleared on a 12-month complete-response measure, and the FDA wants a confirmatory study protocol by the end of 2026.
Voceryq, Inovio's DNA-based treatment for the rare airway disease recurrent respiratory papillomatosis (RRP), won accelerated FDA approval, the company confirmed Monday in an 8-K filing. It had announced the decision on Friday. It is the first product for Inovio, a clinical-stage biotechnology company that develops DNA medicines for HPV-linked diseases, cancer and infectious diseases.
Seven of 26 patients, no surgery
The approval rests on the company's RRP-001 study of 32 adults. Twenty-six of them had needed three or more surgeries in the prior year, a median of 4.5 excisions, and formed the efficacy group.
Seven of those 26 patients (27%, 95% confidence interval 12% to 48%) needed no surgical excision after 12 months of follow-up. Inovio says that outcome is not expected in the natural history of untreated disease. The approval is based on that complete response, defined as no need for surgery in the 12 months after treatment.
On safety, the most common adverse reactions, occurring in more than 5% of patients, were injection site reactions, headache, fatigue, hypertension, nausea and dizziness. Inovio said most were grade 1 or 2 and transient, and all 32 patients completed the study.
Voceryq was approved with Inovio's CELLECTRA 5PSP device, which uses brief electrical pulses to get the DNA plasmids into cells. The regimen is four doses over nine weeks.
A confirmatory study is required
Because the approval is accelerated, continued approval may depend on a confirmatory study. The FDA requires a draft protocol by the end of 2026, with a final protocol targeted by mid-2027.
Inovio's investor presentation describes a planned design of 50 or more adult and pediatric patients with three or more prior surgeries, tracked for at least three years against an external control or justified threshold.
Launch plans and the patient pool
Inovio expects Voceryq to be available to order and ship in about 60 days, with full field deployment in the first quarter of 2027. It has engaged Syneos Health to help recruit and deploy its field teams.
Based on claims data, the company believes at least 25,000 people in the U.S. have RRP. Its presentation says about 400 laryngologists treat most patients and targets insurer policies covering 80% of patients within nine months of approval.
CEO Jacqueline Shea said the company believes the platform has the potential to "transform the treatment paradigm for RRP." Inovio calls Voceryq the first U.S. FDA-approved DNA medicine.
Inovio holds a call at 8:00 a.m. ET on Monday to cover the label and commercialization, and its draft confirmatory-study protocol is due to the FDA by the end of 2026.
Sources
- 8-K Filing — INOVIO PHARMACEUTICALS, INC. (INO) — SEC EDGAR
- Exhibit d150457dex991.htm — INOVIO PHARMACEUTICALS, INC. 8-K exhibit — SEC EDGAR
- Exhibit d150457dex992.htm — INOVIO PHARMACEUTICALS, INC. 8-K exhibit — SEC EDGAR
- Inovio's Voceryq receives FDA accelerated approval for RRP — pharmaceutical-technology.com
- Inovio Gets Accelerated FDA Approval of Voceryq; Shares More Than Triple After Hours — MarketWatch
- Inovio Pharmaceuticals Secures FDA Approval for Voceryq, Revolutionary Treatment for Rare Throat Disease, ETPharma — pharma.economictimes.indiatimes.com
- Why Inovio Pharmaceuticals Shares Are Trading Higher By Over 230%; Here Are 20 Stocks Moving Premarket — benzinga.com
- INOVIO Announces FDA Accelerated Approval of VOCERYQ™, an Immunotherapy to Reduce the Frequency of Surgery in Adults with Recurrent Respiratory Papillomatosis (RRP) — Yahoo Finance
