Paul Healy: EU Approves Frehemgo for Haemophilia A
Paul Healy, Founder of PHARMeMED, Co-Founder and Partner at pharmaCV, shared a post on LinkedIn:
“Novo Nordisk has won EU approval for a new haemophilia A treatment offering patients a choice of weekly, fortnightly or monthly injections.
The European Commission has authorised Frehemgo (denecimig) for adults and children with haemophilia A, including patients who have developed inhibitors against conventional factor VIII replacement therapy.
Haemophilia A is an inherited bleeding disorder in which insufficient factor VIII prevents normal blood clotting, creating risks of spontaneous bleeding and long-term joint damage.
Frehemgo takes a different approach. It is a bispecific antibody that mimics the function of activated factor VIII, helping restore clotting activity without replacing the missing protein itself.
Delivered beneath the skin through a pre-filled pen, it offers three preventive dosing schedules.
The clinical evidence is substantial.
In the phase 3 FRONTIER2 study, weekly and monthly denecimig reduced annualised treated bleeding rates by 96.4% and 98.7%, respectively, compared with on-demand treatment.
Among patients previously receiving preventive clotting factor therapy, reductions were 54.0% and 42.8%.
Additional studies supported use in children, fortnightly administration and direct switching from emicizumab.
Frehemgo adds another option to an increasingly competitive haemophilia treatment landscape. Its longer-term value will depend on clinical experience, access and how its dosing flexibility compares with established therapies.”
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