FDA Grants Accelerated Approval for Voceryq

The FDA just gave the green light to the first plasmid DNA-based immunotherapy ever approved in the United States. Voceryq, made by Inovio Pharmaceuticals, received accelerated approval on March 29, 2024 for adults with recurrent respiratory papillomatosis. The disease causes wart-like growths in the airway and forces patients into endless surgeries. In a 32-patient trial, seven of the 26 participants had three or more surgeries in the prior year. After receiving Voceryq, none of those seven required any additional surgery during the first year. The therapy uses two recombinant plasmids delivered by intramuscular injection and electroporation. It trains the body to recognize and destroy cells infected with HPV 6 or 11, the viruses that cause RRP. Common side effects were mild, like injection-site pain, headache, fatigue, and occasional dizziness. The FDA also gave Voceryq Breakthrough and Orphan Drug designations, and post-approval studies will confirm its long-term benefit. "For patients, that could mean fewer surgeries, fewer disruptions, and more time living their lives on their own terms," said Karim Mikhail, director of CBER.