The British medicines regulator has agreed to broaden the label for Boehringer Ingelheim and Eli Lilly’s heart med Jardiance (empagliflozin).
The decision, which follows approvals from the US Food and Drug Administration and the European Medicines Agency earlier in the year, grants marketing authorization in the country for the use of Jardiance to treat adults with symptomatic chronic heart failure.
The new label will include adults with heart failure with preserved ejection fraction (HFpEF), a currently underserved patient population.
Boehringer’s UK medical affairs head Douglas Clark said around “half of all heart failure cases are HFpEF, which for too long had a lack of approved and effective treatments.”
He added: “We hope the approval of empagliflozin will be transformative for clinicians and those living with this severe, long term condition.”
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze