Roche has announced that its haemophilia therapy Hemlibra has been recommended for EU approval by the Committee for Medicinal Products for Human Use (CHMP).
The European Medicines Agency committee has endorsed Hemlibra for routine prophylaxis of bleeding episodes in people with haemophilia A with factor VIII inhibitors, with the recommendation covering all age groups.
“Roche's Hemlibra has been recommended for European regulatory approval in the treatment of haemophilia A.“
Nearly one in three people with severe haemophilia A develop inhibitors to factor VIII replacement therapies, putting them at greater risk of life-threatening bleeding episodes that can cause long-term joint damage.
The CHMP recommendation is based on the results of two pivotal clinical studies, the phase III HAVEN 1 and HAVEN 2 trials, that have demonstrated the safety and efficacy of the drug in this indication.
Hemlibra is being reviewed under accelerated assessment, a procedure granted to medicines that the CHMP believes are of major interest for public health and therapeutic innovation.
Dr Sandra Horning, Roche's chief medical officer and head of global product development, said: "This positive CHMP opinion represents a significant step towards bringing this new treatment to people with haemophilia A with inhibitors in Europe."
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