Novartis has started the week on a high note, with the pharmaceutical company announcing its plans to terminate a drug trial ahead of schedule. The decision was made on the unanimous recommendation of an independent committee, with the company now seeking approval on the basis of the drug’s positive results thus far.
The drug, LCZ696, was recommended after early results showed that patients trialling it lived longer – and without hospitalization – than patients taking enalapril. Designed to treat heart failure, Novartis is going to present the findings and the case for approval at an upcoming meeting with various global health authorities. Milton Packer, co-Principal investigator of trial, confirmed that the evidence in LCZ696′s favor was indeed strong enough to warrant stopping the trial. “The stopping rule was not on the primary endpoint, it was on cardiovascular death,” he said to Forbes’ Larry Husten. “It was a stopping rule that required a very high level of statistical significance for early termination.”
The news comes in contrast to last week’s response to Serelaxin, another Novartis drug that the U.S. Food and Drug Administration (FDA) turned down for approval. Also intended to treat heart disease, Serelaxin did not present a strong enough case, with minimal evidence to support its claims. Earlier this year, a European advisory committee cast similar judgement, limiting Serelaxin’s future in cardiac medicine.
This article has been extracted from http://www.techtimes.com, please click on this link to read the article in full http://www.techtimes.com/articles/5031/20140331/early-trial-results-of-heart-drug-suggests-novartis-has-a-winner-on-its-hands.htm
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