Shots:
- The US FDA has granted full approval to Papzimeos (zopapogene imadenovec-drba) for adults with recurrent respiratory papillomatosis (RRP), even though its BLA was originally submitted under the accelerated approval pathway
- Approval was based on a P-I/II trial meeting its 1EP of safety as well as efficacy & showed 51% pts (18/35) achieving CR with no surgeries for 12mos., with 15/18 pts maintaining response at 24mos. Papzimeos also induced strong HPV 6/11-specific T cell responses, which was greater in responders; data was presented at ASCO 2024 & published in The Lancet Respiratory Medicine
- Papzimeos is a non-replicating adenoviral vector-based immunotherapy engineered to express a fusion antigen containing selected regions of HPV types 6 and 11 proteins
Ref: Precigen| Image: Precigen| Press Release
Related News:- Sanofi’s Rilzabrutinib Secures the EMA’s Orphan Drug Designation to Treat IgG4-Related Disease
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
