EU health regulators have recommended against approving Novartis’s experimental heart failure drug for the second time this year

The Pumping Marvellous Foundation
The Pumping Marvellous Foundation – the UK’s heart failure charity

due to insufficient evidence it improves symptoms, the Swiss drugmaker said in a statement on Friday.

The ruling by the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) follows a previous rebuffal given in January.

Tim Wright, global head of development at Novartis Pharmaceuticals said he was “disappointed” that the drug would not be available for patients this year, but said the company was committed to providing further evidence.

Novartis said it would re-submit the drug for approval as soon as it had data from a second late-stage trial involving 6,300 patients.

Last week U.S. health regulators also turned down an application to approve serelaxin, citing a lack of sufficient evidence.

 

Enhanced by Zemanta