The drug will be available for patients aged 12 years and older and weighing at least 35 kg.
The Europe an Medicines Agency's Committee for Medicinal Products for Human Use recommended the granting of marketing authorization for for treating bleeding episodes in people aged 12 years or older with severe hemophilia A and B. The drug is now pending a final decision from the Europe an Commission. in December 2023. The EMA will now review available information to determine whether this status can be maintained. The orphan designation is given to drugs intended for use with rare diseases.
Primary endpoints were the annualized bleeding rate for treated bleeding events and safety outcomes. The ABR was calculated as the number of reported bleeding events divided by the number of months in the reporting timeframe, which was then multiplied by 12. After 12 months of treatment, patients had the option to continue the marstacimab regimen as part of a long-term extension study. For up to 16 months, participants experienced consistent reductions in ABR compared with on-demand treatment, and further reductions compared with routine prophylaxis.
Haemophilia Orphan Drugs Drug/Treatment Safety Drug Safety Treatment Safety Drug Development Drug Discovery Drug Pipeline Drug Development Pipeline Drug Legislation Drug Registries Drug Registry Drug Regulation Hemophilia A Haemophilia A Hemophilia B Haemophilia B Europe European Hemorrhage Bleeding Quality Of Life QOL Health Related Quality Of Life
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