RLX030

FDA grants Breakthrough Therapy designation to Novartis’ serelaxin (RLX030) for acute heart failure.

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  • Recognition by the US Food and Drug Administration (FDA) that RLX030 has the potential to address a serious unmet medical need
     
  • If approved, RLX030 has the potential to be the first treatment breakthrough for Acute Heart Failure patients in 20 years[1,2]
     
  • RLX030 is the second Breakthrough Therapy designation by the FDA for Novartis investigational treatments, following LDK378

 

Novartis announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation status to RLX030 (serelaxin), an investigational treatment for patients with acute heart failure (AHF). The FDA has concluded that RLX030 qualifies for a Breakthrough Therapydesignation after considering the available clinical evidence which supports a substantial improvement over currently available therapies for AHF[3], a life-threatening illness.

 

The FDA’s decision was supported by efficacy and safety results from the phase III RELAX-AHF trial, which also showed that patients who received RLX030 had a 37% reduction in mortality at 6 months after an acute heart failure episode compared to those who received conventional treatment[4].

 

Each year around 3.5 million AHF episodes happen in the US and EU alone[5]; this is expected to increase further as the population ages. Every AHF episode contributes to a downward spiral of worsening heart failure and damage to vital organs, such as the heart and kidneys, which decreases the chance of the patient surviving another episode[6]. 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”.

 

RLX030 is currently being assessed by health authorities around the world including the FDA and the European Medicines Agency (EMA) for the treatment of AHF.

 

About RLX030 and Novartis’ commitment to heart failure

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[4]. Data from the clinical trial program has also shown that RLX030’s side effects are comparable to conventional therapy and it was generally well tolerated[4].

 

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.

 

About heart failure

Heart failure is a debilitating and potentially life-threatening condition where the heart cannot pump enough blood around the body. More than 15 million people suffer from heart failure globally and this number is increasing[9]. The condition is often fatal when patients have one or repeated acute heart failure episodes. As an AHF episode approaches, patients become severely breathless and incapacitated and may rapidly gain weight due to fluid build-up in the lungs and around the body.

 

Patients experiencing an AHF episode need to be rushed to the emergency room for urgent treatment, making AHF the most common cause of hospitalization in patients over 65 years.

 

Source: Novartis newsletter.

 

 

 

 

Results from Novartis Phase III study show that RLX030 reduced deaths in patients with acute heart failure.

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  • RELAX-AHF study met one of its two primary endpoints in reducing dyspnea or shortness of breath, and showed RLX030 (serelaxin) was well tolerated[1]
  • Six-month study shows that investigational RLX030 reduced all-cause mortality in patients with acute heart failure (AHF)[1]
  • Results of single Phase III clinical trial to be discussed with health authorities worldwide
  • RELAX-AHF data will be presented at American Heart Association congress in November

Phase III study results show that investigational RLX030 (serelaxin) reduced all-cause mortality in patients with acute heart failure (AHF)[1]. The six-month RELAX-AHF study shows that RLX030 reduces the number of deaths in patients with this disease, which has a higher mortality rate than most other cardiovascular diseases[2].

 

The study had two primary endpoints using different scales to measure reduction in dyspnea, only one of which reached statistical significance[1]. Dyspnea, or shortness of breath, is the most common symptom of AHF[3]. RLX030 was well tolerated in the study[1].

 

RELAX-AHF was a Phase III clinical trial to investigate the efficacy and safety of RLX030 for the treatment of AHF. It was a randomized, double-blind, placebo-controlled study involving 1,161 patients in 11 countries[1]. In the study, RLX030 was given on admission to the hospital in the form of an intravenous infusion for up to 48 hours in addition to loop diuretics and other medicines and was compared to placebo on top of standard of care treatment for AHF[4],[5].

 

The study will be presented at the American Heart Association (AHA) congress in Los Angeles in November, 2012. Novartis will initiate discussions of the results of this single Phase III study with health authorities worldwide shortly.

 

Heart failure is a disease in which the heart is unable to supply enough blood to meet the body’s needs[6],[7]. Around half of all patients die within five years of diagnosis[8], particularly as a result of acute episodes in which their symptoms suddenly become worse and urgent hospital treatment is needed[6]. Acute heart failure (AHF) places an enormous burden on healthcare systems and accounts for around two million hospitalizations each year in the EU and US[9].

 

RLX030 is the first in a new class of medicines and is a recombinant form of the human hormone relaxin-2 which occurs naturally in both men and women[10]. In women, levels of relaxin-2 rise to support important physiological changes during pregnancy[10]. Serelaxin acts by relaxing the blood vessels, leading to reduced stress on the heart and kidneys in both men and women[11].

References

1. Novartis Pharma AG. Data on file.

2. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart Disease and Stroke Statistics – 2011 Update. A Report From the American Heart Association. Circulation. 2011;123:e18-e209.

3. Goldberg RJ, Spencer FA, Szklo-Coxe M, et al. Symptom presentation in patients hospitalized with acute heart failure. Clin Cardiol. 2010;33:e73-80.

4. Clinicaltrials.gov: Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure (RELAX-AHF). http://clinicaltrials.gov/ct2/show/NCT00520806; Accessed September 2012.

5. Ponikowski P, Metra M, Teerlink JR, et al. Design of the RELAXin in Acute Heart Failure Study. Am Heart J. 2012;163:149-55.

6. McMurray JJV, Adamopoulos S, Anker SD, et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012;33:1787-1847.

7. Hunt SA, Abraham WT, Chin MH, et al. 2009 Focused Update Incorporated Into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2009;53:e1-90.

8. Roger VL, Lloyd-Jones DM, Benjamin EJ, et al. Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation. 2012;125:e2-e220.

9. Opportunity Assessment for Relaxin in Acute Heart Failure, Decision Resources. Oct 2010.

10 Dschietzig T, Bartsch C, Baumann G, et al. Relaxin – a pleiotropic hormone and its emerging role for experimental and clinical therapeutics. Pharmacol Therap. 2006;112:38-56.

11. Conrad KP. Unveiling the vasodilatory actions and mechanisms of relaxin. Hypertension. 2010;56:2-9.

Source: Novartis Newsletter.