Drug Overview
Adynovate is a long-acting PEGylated recombinant factor VIII (rfVIII) therapy developed by Baxalta and Nektar Therapeutics as a follow-on to Advate (rfVIII; Shire). Using Nektar’s proprietary technology, Adynovate is manufactured by covalently binding Advate to a branched polyethylene glycol (PEG) reagent. This PEGylation process allows Adynovate to have a half-life that is 1.4–1.5 times longer than its predecessor, making it a more convenient option for patients with hemophilia A receiving prophylactic treatment. Shire assumed full rights to Adynovate upon its acquisition of Baxalta in 2016.
TABLE OF CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Adynovate : Hemophilia
LIST OF FIGURES
8 Figure 1: Adynovate for hemophilia – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary of Adynovate for hemophilia
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of Adynovate for hemophilia
12 Figure 4: Adynovate sales for hemophilia across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES
5 Table 1: Adynovate drug profile
7 Table 2: Adynovate pivotal trial data in hemophilia
13 Table 3: Adynovate sales for hemophilia across the US, Japan, and five major EU markets, by country ($m), 2016–25