Roche flags first case of anti-drug antibodies that forced a patient to drop would-be blockbuster Hemlibra
Roche has raised a warning flag on Hemlibra, noting the first case where a hemophilia patient developed anti-drug antibodies that made the drug ineffective.
A media contact sent a statement to me that was originally circulated on Tuesday. In it, the company stated:
We recently learned that a patient in our phase III HAVEN 2 clinical trial developed a neutralising anti-drug antibody to Hemlibra. As with all therapeutic proteins, there is a potential for the development of anti-drug antibodies with Hemlibra, as indicated in the US and EU Hemlibra product labels. For this patient, the anti-drug antibody resulted in reduced efficacy of Hemlibra. The patient and his family have decided to discontinue treatment with Hemlibra, and he will resume treatment with his previous medicine.
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