The U.S. Food and Drug Administration today granted accelerated approval for Voceryq to treat adults with recurrent respiratory papillomatosis.
The rare, chronic disease is caused by human papillomavirus types 6 and 11, which create wart-like growths in the airways that can restrict breathing and affect the voice. Voceryq is the first plasmid DNA-based immunotherapy approved in the United States, according to the FDA. The treatment offers a new option that targets the root cause of the condition to reduce the need for repeated surgeries, the agency said.
The therapy delivers genetic instructions for specific HPV proteins and an immune response-enhancing molecule to stimulate the body to attack infected cells. It is administered through an intramuscular injection using a device that applies brief electrical pulses to help the drug enter the cells.
The agency based the approval on a clinical trial of 32 adults. Out of 26 patients who previously had at least three surgeries, seven required no surgical intervention during the first year after receiving the treatment, the agency said. Common adverse reactions included injection site reactions, headache, fatigue, high blood pressure, nausea and dizziness.
Because the agency granted accelerated approval based on an intermediate clinical endpoint reasonably likely to predict clinical benefit, manufacturer Inovio Pharmaceuticals Inc. must conduct post-approval clinical trials to verify the drug’s clinical benefit, the FDA said.