Zhong X, Wang Y, He X, He X, Hu Z, Huang H, et al
& Rasheed, Z
Key Characteristics of Cagrilintide (5mg) Long-Acting Amylin Analogue : Cagrilintide is designed to activate amylin and calcitonin receptors with a prolonged duration of action compared to natural amylin, supporting models that require sustained receptor activation
Under clinical supervision with proper selection and dosing, peptide therapy is generally well tolerated for appropriate candidates
With respect to the substantial similarity criteria, the applicant asserted that VANFLYTA is not substantially similar to other currently available technologies because VANFLYTA is the first drug to be expressly developed ( as a FLT3 inhibitor, not a multi-kinase inhibitor, and specifically optimized to inhibit the FLT3-ITD AML, thereby targeting the subpopulation of newly diagnosed patients with the worst prognosis (higher risk of relapse and worse overall survival)
All data were acquired and processed using Bruker Topspin 4.0