Basel, May 23, 2014 - Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion for the use of RLX030 (serelaxin) in the treatment of acute heart failure (AHF) indicating that further evidence is required for a license to be granted in the EU.
星期五, 2014, 5月 23 - 13:36
CHMP confirms negative opinion following re-examination of RLX030 - further evidence is required
Novartis aims to resubmit for approval with data from ongoing second Phase 3 study (RELAX-AHF-2)
Basel, May 23, 2014 - Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion for the use of RLX030 (serelaxin) in the treatment of acute heart failure (AHF) indicating that further evidence is required for a license to be granted in the EU. This follows the company's request for re-examination after a previous negative opinion was issued in January. Novartis aims to resubmit for approval as soon as additional data is available from the ongoing global trial program, including the 6,300 patient RELAX-AHF-2 study, one of the largest and most robust programs undertaken by a company for an AHF drug.
"We are disappointed that patients in Europe will not have access to RLX030 in 2014 but we believe in the value that RLX030 can bring to patients and are committed to extending the current evidence base to confirm this," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "20 million people across the world face poor quality of life and high risk of death from heart failure and it remains our mission to change the course of this disease with our research and development efforts."
Heart failure is a debilitating and potentially life-threatening condition where the heart cannot pump enough blood around the body. This, in most cases, happens because the heart muscle responsible for the pumping action weakens over time or becomes too stiff. Heart failure is a significant and growing public health concern affecting over 20 million people worldwide, and costing the world economy $45 billion annually.-
Novartis is committed to research in heart failure with a portfolio including RLX030 for acute heart failure and LCZ696 for chronic heart failure.
About RLX030 and Acute Heart Failure Patients experiencing an AHF episode have rapidly worsening, life-threatening symptoms requiring urgent hospital treatment, including difficulty breathing and swelling around the body as fluid accumulates in the lungs and tissues. Despite significant progress in other heart conditions, there have been no treatment breakthroughs for AHF in 20 years. Commonly used medicines only treat the immediate symptoms and have not been proven to have an impact on longer-term outcomes-.
RLX030 is a form of a naturally occurring hormone (human relaxin 2) present in both men and women which rises in women during pregnancy to help the body cope with the additional cardiovascular demands., It has multiple effects including relaxing the blood vessels and reducing fluid buildup. Some evidence also suggests it can reduce damage to heart and vital organs, which may be of particular importance when considering the cascade of damage that occurs during an AHF episode.,,
Disclaimer The foregoing release contains forward-looking statements that can be identified by words such as "aims," "negative opinion," "as soon as," "will," "believe," "can," "committed," "mission," "growing," "suggests," "may," or similar terms, or by express or implied discussions regarding potential marketing approvals for RLX030 or LCZ696, or regarding potential future revenues from RLX030 and LCZ696. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that RLX030 or LCZ696 will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that RLX030 or LCZ696 will be commercially successful in the future. In particular, management's expectations regarding RLX030 and LCZ696 could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.
References  Harrison's 'Principles of Internal Medicine', Seventeenth Edition pages 1442 - 1455  Gheorghiade M, Pang P, Acute heart failure syndromes, Journal of the American College of Cardiology 2009; 53 (7):557-73  Go AS, Mozaffarian D, Roger VL, et al. American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics-2014 update: a report from the American Heart Association. Circulation. 2014;128:00-00  Lloyd-Jones et al. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010;121:e46-215  Berry et al. Economics of chronic heart failure. Eur J Heart Fail. 2001;3:283291  Stewart et al. The current cost of heart failure to the National Health Service in the UK. Eur J Heart Fail. 2002;4:361371  Cowie et al, Acute heart failure - a call to action, The British Journal of Cardiology, 2013, 20(2):S1-S11  Hunt S et al. 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 Developed in Collaboration With the International Society for Heart and Lung Transplantation. Circulation. 2009;119:e391-e479  McMurray 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  Gheorghiade et al. The challenge of acute heart failure syndromes. Am J Cardiol. 2005;96:86G89.  Teichman S et al. Relaxin, a pleiotropic vasodilator for the treatment of heart failure. Heart Fail Rev. 2009;14:321-329  Teichman SL et al. Relaxin: Review of biology and potential role in treating heart failure. Curr Heart Fail Rep. 2010;7:75-82  Teerlink JR, Cotter G, Felker GM, et al. Serelaxin, recombinant human relaxin-2, for treatment of acute heart failure (RELAX-AHF): a randomised, placebo-controlled trial. Lancet. 2013;381:29-39.  Metra M, Cotter G, Davison BA, et al. Effect of Serelaxin on Cardiac, Renal, and Hepatic Biomarkers in the Relaxin in Acute Heart Failure (RELAX-AHF) Development Program. J Am Coll Cardiol. 2013;61:196-206.
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff Novartis Global Media Relations +41 61 324 7999 (direct) +41 79 593 4202 (mobile) [email protected]
Dermot Doherty Novartis Global Media Relations +41 61 696 8653 (direct) +41 79 536 9755 (mobile) [email protected]