Shots:

• 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)

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