MHRA approves Alhemo to prevent or reduce bleeding episode frequency
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine Alhemo (concizumab) to prevent or reduce the frequency of bleeding episodes (prophylaxis) in people aged 12 years and older with hemophilia A or B with inhibitors. Concizumab is injected subcutaneously daily.
The new marketing authorization was granted to Denmark’s Novo Nordisk (NOV: N), which gained approval for the drug in the USA in December last year for the same indication. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Alhemo earlier this year. This also another move by the company to expand beyond its core mega blockbuster diabetes and obesity portfolio based on semaglutide.
However, Novo Nordisk must await clearance from the UK health technology assessor, the National Institute for Healthcare Excellence (NICE), before Alhemo can be prescribed on the National Health Service (NHS) and pricing has been agreed.
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