FDA rejects Novartis’ ‘breakthrough’ cardio drug serelaxin
The FDA’s very new initiative Breakthrough Therapy Designation seems to be a very speedy review and also gives regulators a front seat, however as Novartis have found out it doesn’t mean guaranteed approval. The FDA rejected the heart drug serelaxin, which is the latest blow to Novartis who hoped it could be the leading light of a cardiovascular franchise.
The FDA said it needed more evidence of the efficacy before it could approve the treatment, a synthetic form of the hormone relaxin. Relaxin is designed to ease blood vessels and also treat acute heart failure. This now means waiting for data from Novartis current phase III trial, with results not expected until 2016.
The rejection comes as little surprise after members of the FDA advisers voted unanimously against recommending approval for serelaxin in March. Resulting in Novartis to think over the design of its trial, gaps in the provided data and serious questions over serelaxin’s efficacy. This had been echoed in a harsh review from FDA staff, the panel said Novartis failed to confirm the drug’s effect on shortness of breath and the rate of heart failure.
Despite this setback and a rejection earlier in the year from the European Medicines Agency Novartis remains confident in serelaxin. Belieieving that it could eventually launch the cardio treatment worldwide and dampen effects of patent losses to the likes of Diovan and Gleevac
Tim Wright Global Head of Development of Novartis, continues to believe that serelaxin has the potential to be an important in acute heart failure. He also said they had been encouraged by the feedback from the FDA, “In accordance with the FDA’s advice, we will continue to expedite our clinical trial program to build the supporting body of evidence.”
Serelaxin had been among the first drugs added to the FDA’s breakthrough therapies, joining a program that has shepherded the likes of; Roche, Johnson & Johnson and Gilead Sciences to early approvals. Novartis have touted serelaxin as a blockbuster in the making, expecting sale to peak well above a billion dollars a year.