The FDA has granted accelerated approval to Voceryq, the first plasmid DNA-based immunotherapy approved in the U.S., for adults with recurrent respiratory papillomatosis.
The therapy, also known as doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd, was approved Oct. 30, according to an FDA news release. Recurrent respiratory papillomatosis is a rare, chronic disease caused by HPV types 6 and 11 that leads to wart-like growths in the airways and can require repeated surgical procedures.
The FDA based the accelerated approval on an open-label, multicenter clinical trial involving 32 adults. Seven of 26 patients (27%) who had at least three baseline surgeries did not require any surgical intervention during the first year after treatment.
Voceryq delivers two plasmids into the body’s cells and is designed to stimulate an immune response against cells infected by HPV types 6 and 11. It is administered via intramuscular injection using the CELLECTRA 5PSP Device.
The FDA granted Voceryq breakthrough and orphan drug designations. The accelerated approval was granted to Inovio Pharmaceuticals.
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