FDA grants Breakthrough Therapy status to Novartis' heart failure drug serelaxin

BASEL, Switzerland—Novartis announced June 21 that the U.S. Food andDrug Administration (FDA) had granted the Breakthrough Therapy designationto its compound serelaxin (RLX030), an investigational treatment for patientswith acute heart failure (AHF).

As Novartis notes, the FDA decided that RLX030qualified for the status after it considered "theavailable clinical evidence, which supports a substantial improvementover currently available therapies for AHF, a life-threateningillness."

According to Novartis, the FDA`s decision was supported by efficacy and safety results from thephase III RELAX-AHF trial, which showed that patients who receivedRLX030 had a 37-percent reduction in mortality at six months after an acuteheart failure episode compared to those who received conventionaltreatment.

Each year, the company notes, some 3.5 million AHF episodes occur in the European Union and United States, not to mention episodes in the rest of the world, and this number is expected to increase further as the population ages.

Every AHF episode contributes to a downward spiral of worsening heartfailure and damage to vital organs, such as the heart and kidneys, whichdecreases the chance of the patient surviving another episode, Novartis notes, adding that thereis "an urgent need" for new treatments that help relieve patients`symptoms and protect the vital organs against damage during an AHFepisode, as well as have the potential to increase life expectancy inthe AHF patient population.

"RLX030 is representative of Novartis` strong commitment to developinnovative treatments for patients in areas of significant unmet need,"said David Epstein, division head of Novartis Pharmaceuticals. "Commonlyused medicines for AHF only improve the immediate symptoms, so theadditional effect on survival observed with RLX030 offers hope topatients and physicians."

RLX030 (serelaxin) is a form of a naturally occurring hormone (humanrelaxin-2), present in both men and women, although its levels risein pregnant women to help the body cope with the additionalcardiovascular demands during pregnancy. RLX030 is proposed foradministration on admission to the emergency room to patientsexperiencing an AHF episode and is infused over a 48-hour period, inaddition to conventional therapies.