Drugs and FDA
FDA approves Inovio’s Voceryq for adults with recurrent respiratory papillomatosis
Voceryq received accelerated FDA approval to reduce surgery frequency in adults with recurrent respiratory papillomatosis, but treatment starts with surgery to remove visible growths.
The FDA granted accelerated approval to Inovio’s Voceryq to reduce the frequency of surgeries in adults with recurrent respiratory papillomatosis, a condition that causes growths in the airways. The treatment uses two plasmids to prompt an immune response against HPV types 6 and 11. Patients first need surgery to remove visible growths, then receive four doses, one every 3 weeks.
The approval was based on an open-label phase I/II trial of 32 adults. MedPage Today reported that 27% of the 26 patients who had at least three surgeries in the 12 months before treatment had a complete response, meaning they needed no surgical excisions during 12 months of follow-up. MedCity News reported that seven of those 26 patients had a complete response. The FDA also approved Inovio’s delivery device. Inovio must conduct a confirmatory study to verify the therapy’s clinical benefit.
