Inovio Wins FDA Approval for VOCERYQ, Its First Commercial Product
The accelerated approval is based on a complete response in 26 patients and could reduce repeated surgeries for a rare airway disease.
- On Friday, the U.S. Food and Drug Administration granted accelerated approval to Inovio Pharmaceuticals' Voceryq, marking the first FDA-approved DNA medicine for treating recurrent respiratory papillomatosis .
- Recurrent respiratory papillomatosis affects at least 25,000 patients in the United States, forcing repeated surgeries to remove papillomas that frequently regrow and threaten permanent vocal cord damage.
- Clinical data showed 27% of patients achieved complete response with no surgical excision needed after 12 months, while treatment caused only transient grade 1 and 2 adverse reactions.
- RRP Foundation President Kim McClellan said the therapy provides "a non-surgical treatment option," while Inovio President and Chief Executive Officer Dr. Jacqueline Shea called it a potential "paradigm shift."
- The company expects to ship Voceryq in approximately 60 days with full commercial launch in early 2027, and will host a conference call Monday, November 2, 2026 for investor details.
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46 Articles
Novel Therapy Lands Speedy Approval for Wart-Like Airway Disease
(MedPage Today) -- The FDA granted accelerated approval to doruxapapogene ralaplasmid and lalikinogene sifuplasmid (Voceryq) to reduce the frequency of surgical papilloma excisions in adults with recurrent respiratory papillomatosis (RRP), the...
Inovio Wins FDA Approval for VOCERYQ, Its First Commercial Product
Inovio Pharmaceuticals (NASDAQ:INO) said the U.S. Food and Drug Administration granted accelerated approval to VOCERYQ, formerly known as INO-3107, as a nonsurgical treatment intended to reduce the frequency of surgeries in adults with recurrent respiratory papillomatosis, or RRP. VOCERYQ is the co
New DNA-based therapy offers adults with recurrent HPV airway disease an alternative to repeated surgeries
The FDA granted accelerated approval to Inovio's Voceryq for adults with recurrent respiratory papillomatosis, a rare HPV-related airway disease requiring repeated surgeries.
INOVIO Announces FDA Accelerated Approval of VOCERYQ™, an Immunotherapy to Reduce the Frequency of Surgery in Adults with Recurrent Respiratory Papillomatosis (RRP)
INOVIO delivers a new nonsurgical treatment option with a broad indication for adults living with RRP, a rare and debilitating disease that often requires surgeryVOCERYQ™ is a plasmid DNA-based immunotherapy that targets the root cause of RRP: HPV-6 and HPV-11INOVIO…
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