Alvotech has reported data from the confirmatory P-III (AVT03-GL-C01) trial assessing the efficacy, safety, immunogenicity & PK of AVT03 vs Prolia postmenopausal women (n=532) with osteoporosis. Results will form the basis of other indications for AVT03 with global regulatory submissions expected in H2’24
The trial reached its 1EP of change in bone mass density (BMD) from baseline and a bone resorption biomarker, evaluated at 6 & 12mos.; follow-up will continue till 18mos. (study’s end)
Another two P-I (AVT03-GL-P01: n=209 & AVT03-GL-P03: n=208) trials comparing AVT03 with Prolia & Xgeva, respectively, among healthy adults also reached its 1EPs
Ref: Alvotech | Image: Alvotech
Related News:- Alvotech and STADA Extend their Strategic Partnership Covering AVT03 (Biosimilar, Denosumab)
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
