Swiss drug major Novartis (NOVN: VX) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has granted accelerated assessment to LCZ696, an investigational medicine for patients with heart failure with reduced ejection fraction (HFrEF).
Novartis said the expedited review procedure has never been awarded in the cardiovascular area until now. The designation allows the CHMP to grant an opinion at day 150 versus a normal 210 day procedure. A decision on EU approval is expected at some point next year.
David Epstein, division head, Novartis Pharmaceuticals, said: “Novartis is committed to extending and improving more lives sooner with LCZ696, and this decision by the CHMP we hope will greatly support our effort to do so in Europe.”
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