- FDA granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for adults with recurrent respiratory papillomatosis (RRP), a rare HPV-caused disease.
- The approval rests on a reduction in the frequency of surgical procedures, an intermediate endpoint reasonably likely to predict clinical benefit; the manufacturer must run post-approval trials to verify clinical benefit.
- In the open-label trial of 32 adults, 7 of 26 patients with at least three baseline surgeries required no surgical intervention in the first year after treatment.
- The FDA granted Voceryq Breakthrough and Orphan Drug designations; the body names Inovio Pharmaceuticals, Inc. as the recipient of the accelerated approval.
Quotes
“a plasmid DNA-based immunotherapy that harnesses the body’s own immune system to fight the underlying cause of RRP”
“Seven (27%) out of 26 patients who had at least three baseline surgeries did not require any surgery intervention during the first year after treatment.”