FDA Approves Inovio’s VOCERYQ to Reduce RRP Surgery Frequency

The U.S. Food and Drug Administration (FDA) approved Inovio Pharmaceuticals’ VOCERYQ on Oct. 30 to reduce the frequency of surgical papilloma excisions in adults with recurrent respiratory papillomatosis (RRP).

The accelerated approval covers adults with RRP, a condition associated primarily with human papillomavirus types 6 and 11. Surgery to remove papillomas is a standard treatment, though the growths often return.

In Inovio’s RRP-001 study, 32 adults were evaluated. Of the 26 patients in the efficacy group, seven, or 27%, had no surgical excision during the 12 months after treatment. The 95% confidence interval for that result was 12% to 48%.

Inovio said continued approval may depend on confirming clinical benefit in additional studies. Jacqueline Shea, INOVIO president and CEO, said the company sees the treatment as a potential patient-focused option for RRP.

The company expects VOCERYQ to be available to order and ship in about 60 days, with full field deployment in the first quarter of 2027.