ZURICH (Reuters) - EU health regulators have recommended against approving Novartis’s experimental heart failure drug for the second time this year 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 and dashes Novartis’s hopes for approval of serelaxin in Europe this year.
The Basel-based firm was banking on serelaxin, also known as RLX030, to help replace lost revenue from blood pressure pill Diovan which faces competition from cheap, copycat medicines.
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.
About 5 million people in the United States are living with chronic heart failure, a progressive weakening of the heart, according to Novartis. About 1 million people are hospitalized with episodes of acute heart failure, and about 22 percent of patients who are hospitalized die within a year.
Reporting by Caroline Copley; Editing by Greg Mahlich