FDA panel rejects serelaxin approval for heart failure, but urges future study
AT AN FDA ADVISORY COMMITTEE MEETING
In a statement issued after the meeting, Tim Wright, global head of development at Novartis, said that the discussion during the meeting "provided important information that we will address with the FDA as it completes its review," and that the company will "continue to drive our robust clinical trial program and build upon the already established body of evidence." In 2013, Novartis started enrolling patients in RELAX-AHF-2, an international, phase III outcomes study of serelaxin in more than 6,300 patients with acute heart failure; results are expected in 2016.
Serelaxin has not been approved elsewhere. The FDA granted serelaxin fast track status in 2009, and in 2013 it was granted breakthrough therapy designation for reduction of cardiovascular mortality. Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.
In January, the Committee for Medicinal Products for Human Use recommended against approving serelaxin for acute heart failure in Europe, citing issues that included no apparent benefit for short-term relief of dyspnea.
The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver, but not at this meeting.
