Heartbreak for Novartis as FDA rejects drug
pharmafile | May 18, 2014 | News story | Research and Development, Sales and Marketing | GSK, Novartis, heart drug
Novartis has been delivered a blow by the US Food and Drug Administration as the regulator says it needs further evidence for the Swiss firm’s heart medicine RLX030.
Rejecting the drug, the FDA says in its complete response letter that further evidence on the efficacy of RLX030 (serelaxin) for the treatment of acute heart failure (AHF) is required for a US licence to be granted.
While disappointing, Novartis must have been expecting it: in March an internal FDA document said much the same, criticising the lack of data.
A briefing for the FDA’s Cardiovascular and Renal Drugs Advisory Committee expressed serious concerns over 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 explains, adding that the trial results do not even provide “persuasive evidence of an effect on dyspnoea”.
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.
But Novartis is still putting a brave face on its prospects, insisting that the second part of the Phase III study RELAX-AHF-2, which will enroll over 6,300 patients, is ‘progressing well’ and that it intends to resubmit the drug when additional data is available.
The relaxin receptor agonist is a form of the naturally-occurring hormone human relaxin 2, which can relax the blood vessels and reduce fluid build-up – and Novartis suggests RLX030 can also reduce the damage to the heart and vital organs caused by each AHF episode.
“We continue to believe RLX030 has the potential to be an important treatment for AHF and have been encouraged by feedback from FDA advisory committee members noting the data are intriguing,” says Tim Wright, global head of development for Novartis Pharmaceuticals.
“In accordance with the FDA’s advice we will continue to expedite our clinical trial programme to build the supporting body of evidence,” he added.
Heart failure affects over 20 million people worldwide and costs the global economy $45 billion annually, Novartis says. There are around 3.5 million AHF episodes in the US and EU each year, a figure expected to increase further as the population ages.
Analysts believe that the Swiss company, with serelaxin plus another heart failure treatment in late-stage development called LCZ696, could be on the brink of a new multi-billion dollar franchise.
It is a competitive area as last week, GlaxoSmithKline’s experimental heart drug darapladib failed to meet its primary endpoint in a Phase III trial for the second time in little more than six months, not reducing the risk of cardiovascular events such as heart attack versus placebo when added to standard of care.
Adam Hill
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