一次情報の記録
FDAは、RRP-001試験における完全奏効（12か月間に外科手術なし）に基づき、成人のRRPにおける外科的乳頭腫切除の頻度を減少させるためにVOCERYQの迅速承認を付与しました。継続承認は確認試験に依存し、ドラフトプロトコルは2026年末までに提出予定です。これは初めて承認されたDNA医薬品であり、市販は約60日以内に開始され、完全発売は2027年第1四半期となる見込みです。
INOVIO Announces FDA Accelerated Approval of VOCERYQ™, an Immunotherapy to Reduce the Frequency of Surgery in Adults with Recurrent Respiratory Papillomatosis (RRP) INOVIO Announces FDA Accelerated Approval of VOCERYQ™, an Immunotherapy to Reduce the Frequency of Surgery in Adults with Recurrent Respiratory Papillomatosis (RRP) News provided by INOVIO Pharmaceuticals, Inc. Oct 30, 2026, 18:01 ET Share this article Share this article INOVIO delivers a new nonsurgical treatment option with a broad indication for adults living with RRP, a rare and debilitating disease that often requires surgery VOCERYQ ™ is a plasmid DNA-based immunotherapy that targets the root cause of RRP: HPV-6 and HPV-11 INOVIO expects to make VOCERYQ available to order and ship in approximately 60 days, with ful