The U.S. Food and Drug Administration granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for the treatment of adults with recurrent respiratory papillomatosis on Friday.

Voceryq is the first plasmid DNA-based immunotherapy approved in the U.S. The drug targets the root cause of recurrent respiratory papillomatosis, a rare disease caused by human papillomavirus that leads to the formation of small, wart-like growths in the patient’s airways.

The safety and effectiveness evaluation involved an open-label multicenter clinical trial in 32 adults diagnosed with recurrent respiratory papillomatosis. Seven out of 26 patients with at least three baseline surgeries required no surgical intervention during the first year after treatment.

Voceryq is administered via intramuscular injection using the CELLECTRA 5PSP Device to facilitate electroporation. The most commonly reported adverse reactions included injection site reactions, headache, fatigue, hypertension, nausea, and dizziness. The manufacturer must conduct post-approval clinical trials to verify and describe Voceryq’s clinical benefit.