FDA unconvinced on Novartis heart drug
pharmafile | March 26, 2014 | News story | Research and Development, Sales and Marketing | FDA, Novartis, ahf, heart, serelaxin
The prospects of Novartis’ latest heart drug being approved in the US anytime soon appear to have been scuppered by an internal FDA document criticising a lack of data.
“We recommend that serelaxin not be approved at this time because there is insufficient evidence to support the proposed indication,” says the FDA in a briefing for the meeting of its own Cardiovascular and Renal Drugs Advisory Committee, which is scheduled for Thursday.
Novartis hopes serelaxin will be given authorisation to improve the symptoms of acute heart failure (AHF) – which affects more than 15 million patients around the world and is one of the leading causes of emergency hospitalisation – through reducing the rate at which the condition worsens.
However, the FDA makes clear is has serious concerns, not least the fact that the support for efficacy comes from a single trial, RELAX-AHF, whose primary objective was to demonstrate that serelaxin improves dyspnoea in heart patients.
“The applicant is seeking a somewhat different claim,” the FDA briefing note says – before going on to suggest that the trial results do not even provide “persuasive evidence of an effect on dyspnoea”.
To make matters worse, it adds: “We do not believe that the data from the trial support the claim that serelaxin reduced the rate of worsening of heart failure.”
It had all looked so promising last year when the US regulator granted serelaxin, which has also been filed with the European Medicines Agency, breakthrough therapy designation status.
Each year around 3.5 million AHF episodes happen in the US and EU alone, a figure expected to increase further as the population ages – and these each cause damage to vital organs, such as the heart and kidneys.
Novartis really needs approval since analysts believe that with serelaxin, plus another heart failure treatment in late-stage development, LCZ696, Novartis could have a new multi-billion dollar franchise.
While the FDA pre-meeting document makes pretty chastening reading for Novartis, there may be a chink of light: the regulator suggests that the drug will not have a problem with safety.
The Swiss manufacturer is currently conducting a large outcome trial to confirm the favourable mortality finding seen in RELAX-AHF and the exploratory dose-finding study, Pre-RELAX-AHF.
Adam Hill
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