Daiichi Sankyo scores first nod for IV iron replacement drug in patients with heart failure
Daiichi Sankyo is expanding the label of its iron replacement injectable, Injectafer, into a first-of-its-kind indication, according to the company — iron deficiency in adult patients with heart failure in a bid to expand exercise capacity.
The expansion was supported with data from CONFIRM-HF, a 304-patient, placebo-controlled Phase IV trial.
The study, completed in 2015, found that Injectafer “significantly improved” exercise capacity compared to placebo as measured by a 6-minute walk test. The most common treatment-emergent adverse events were headache, nausea, hypertension, injection site reactions, hypophosphatemia and dizziness.
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