Heart failure treatment given Breakthrough Status
pharmafile | June 27, 2013 | News story | Sales and Marketing |Â Â Breakthrough Therapy Designation, Novartis, RLX03O, serelaxinÂ
Novartis’ new treatment for heart failure has been granted Breakthrough Therapy designation status by the FDA.
RLX030 (serelaxin) is for patients with acute heart failure (AHF), a condition affecting more than 15 million patients around the world, and one of the leading causes of emergency hospitalisation.
The FDA granted the special status to RLX030 after reviewing clinical data, which supports a substantial improvement over currently available therapies for AHF, a life-threatening illness.
Novartis’ phase III RELAX-AHF trial showed that patients who received RLX030 had a 37% reduction in mortality at six months after an acute heart failure episode compared to those who received conventional treatment.
Novartis have another heart failure treatment in late-stage development, LCZ696, which is targeted at chronic heart failure rather than acute heart failure. Analysts believe that if both drugs are approved, Novartis could have on its hands a multi-billon dollar franchise in heart failure.
Each year around 3.5 million AHF episodes happen in the US and EU alone, a figure expected to increase further as the population ages. Every AHF episode contributes to a deterioration in heart failure and damage to vital organs, such as the heart and kidneys, which decreases the chance of the patient surviving another episode. There is an urgent need for new treatments that help relieve patients’ symptoms and protect the vital organs against damage during an AHF episode, as well as have the potential to increase life expectancy in the AHF patient population.
“RLX030 is representative of Novartis’ strong commitment to develop innovative treatments for patients in areas of significant unmet need,” said David Epstein, Division Head of Novartis Pharmaceuticals. “Commonly used medicines for AHF only improve the immediate symptoms, so the additional effect on survival observed with RLX030 offers hope to patients and physicians”.
The Breakthrough Therapy designation means that RLX030 will be given priority status for review, with the FDA advising Novartis to ensure the data package is robust enough to maximise the chance of approval. The drug has already been filed with the European Medicines Agency.
About RLX030
RLX030 (serelaxin) is a form of a naturally occurring hormone (human relaxin-2), present in both men and women[7], although its levels rise in pregnant women to help the body cope with the additional cardiovascular demands during pregnancy[8]. RLX030 is proposed for administration on admission to the emergency room to patients experiencing an AHF episode and is infused over a 48 hour period, in addition to conventional therapies.
In RELAX-AHF, RLX030 was shown to have both short and longer-term effects, helping patients breathe during and after an AHF episode, reducing the rate of heart failure worsening. Data from the clinical trial programme has also shown that RLX030’s side effects are comparable to conventional therapy and it was generally well tolerated.
Another Novartis compound called LCZ696, an angiotensin receptor neprilysin inhibitor, is the first in a new class of dual acting drugs being evaluated for the treatment of chronic heart failure. A robust clinical development program including two global phase III studies (PARAGON-HF and PARADIGM-HF) is underway to fully assess the efficacy and safety profile of LCZ696.
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