For Novartis, No Relax’in On Serelaxin: More Trials Likely
This article was originally published in The Pink Sheet Daily
Executive Summary
Novartis released mixed Phase III data on its heart failure candidate at the American Heart Association Scientific Sessions, showing the drug reduced symptoms of acute heart failure but failed to demonstrate an improvement on a second endpoint, cardiovascular death and hospital stays at 60 days.
You may also be interested in...
Stick To Basics: Attempt To Improve Heart Failure Symptomatic Endpoint Trips Up Novartis’ Serelaxin
While on paper a surrogate endpoint was OK with the agency, company’s attempt to advance endpoint by incorporating clinical outcomes gets pushback from FDA and its advisors.
FDA Advisors Think Novartis’ Serelaxin Could Perform Better On More Difficult Endpoints
Advisory committee rejects heart failure treatment but expects drug may show success if evaluated on harder clinical endpoints.
Novartis Likely Stuck Waiting For Second Phase III For Serelaxin Approval
FDA recommends against approval of Novartis’ heart failure drug serelaxin in run up to advisory panel, signaling company may need second Phase III study just beginning to get drug okayed.