Shots:
- The CHMP has recommended Frehemgo (QM, Q2W or QW) to treat haemophilia A, with or without inhibitors, in adults & children, based on the FRONTIER program; launch is expected in the first EU countries in Q4’26 & broadly across the EU starting early 2027
- FRONTIER 2 trial showed Frehemgo significantly reduced annualized bleeding rates (ABR) vs prior factor prophylaxis & on-demand treatment, with or without inhibitors, while FRONTIER 3 showed consistent efficacy in children (<12yrs.)
- Across the program, mean ABRs were generally <1 in P-III populations, with many pts experiencing zero treated bleeds, while FRONTIER 5 identified no new safety signals after switching from emicizumab & showed a clear preference for the Frehemgodevice
Ref: Globenewswire | Image: Novo | Press Release
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