BASEL, SWITZERLAND - OCTOBER 25:  A general vi...New Novartis Heart Failure Drug

Novartis is a leading Pharmaceutical company who has developed a potential new drug to focus on acute Heart Failure. You will see a lot more activity from device and pharma companies in the future on new drugs and treatments. This is all to do with the size of the market opportunities that exist around preventing hospital admissions and re-admissions. Anyway enjoy the commentary and if you don’t understand it see it as a positive step towards helping heart failure patients.

Novartis a pharma company based in Basle, Switzerland said the drug, serelaxin, reduced shortness of breath for up to five days using one measure, but results weren’t significant, using another, which looked at a shorter time frame.

However the trial was deemed successful because only one of the main study goals had to be met. Serelaxin was given to patients upon hospitalization via a 48-hour infusion. The study failed to show that it kept patients alive or out of hospital longer than the standard treatment, meaning that it failed a secondary study goal to demonstrate the drug’s working. It did, however, show a reduction of 37% in all-cause mortality compared with placebo at the end of six months. The drug was also shown to improve a measure of kidney function, doctors said. Side effects were balanced between treatment groups, suggesting the drug is safe.

Results from the study were good enough to give Novartis the confidence to start talks with health regulators in Europe and the U.S. as it hopes to file the drug for approval next year, Dr. Ameet Nathwani, a cardiologist and global business franchise head critical care at Novartis said “It is the first time in acute heart failure that a drug showed a reduction in mortality.”

Novartis sponsored the study, which involved 1,161 patients. It was to be presented at the American Heart Association conference Tuesday in Los Angeles and published in an upcoming issue of medical journal The Lancet. Novartis said the drug was well tolerated, with side effects such as low blood pressure generally comparable to placebo.

A treatment for acute heart failure would fill an important unmet medical need.

“While we have good medications at hand which can improve the symptoms and the prognosis of patients with chronic heart failure, there is currently no good treatment if the situation becomes suddenly worse,” said Dr. Pascal Meier, a cardiologist and assistant professor adjunct at Yale Medical School. Current treatments merely ease the symptoms, without addressing the condition. “New treatment options for these patients are urgently needed,” said Dr. Meier, who wasn’t involved in the study.

 

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