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.
Novartis is looking for a win, as its main cash cow Diovan (used to treat less-than-optimal blood pressure) is no longer cornering its section of the market, with generic options becoming more and more prevalent. Diovan, previously raking in around $6 billion annually, is no longer protected by patent laws, allowing other pharmaceutical manufacturers to create close replications of the drug that are equally effective. The patents began to expire globally in 2011, causing Novartis to grasp for a new best seller.
Novartis hopes to revive its reputation as the go-to pharma company for cardiovascular medicine, a reputation that LCZ696 could bolster if approved. According to an advisory note by Citibank analyst Andrew Baum, LCZ696, if approved, will be the first option for chronic cardiac failure approved in ten years, with revenue reaching $5 billion annually.
