FDA Grants Accelerated Approval to Voceryq, the First Plasmid DNA-Based Immunotherapy in the U.S., for a Rare Airway Disease
The U.S. Food and Drug Administration on October 30 granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for the treatment of adults with recurrent respiratory papillomatosis (RRP), a rare disease caused by human papillomavirus (HPV) that leads to small, wart-like growths in the airways. It is the first approval of a plasmid DNA-based immunotherapy in the United States, offering patients a new option that targets the root cause of RRP rather than only its symptoms and has been shown to reduce the burden of surgical intervention.
Adults living with RRP often face an exhausting cycle of repeated surgeries, managing the disease without ever truly escaping it. The new therapy harnesses the body's own immune system against the underlying cause.
"Today's approval represents a meaningful scientific breakthrough: a plasmid DNA-based immunotherapy that harnesses the body's own immune system to fight the underlying cause of RRP," said Karim Mikhail, Director of the Center for Biologics Evaluation and Research. "For patients, that could mean fewer surgeries, fewer disruptions, and more time living their lives on their own terms."
Source: GSM · USA (original Chinese edition)
Photo: 图： FDA 国家毒理研究中心实验室。美国食品药品监督管理局，公共领域。 / A laboratory at the FDA's National Center for Toxicological Research. U.S. Food and Drug Administration, public domain.
