PRESS RELEASE: Novartis Heart Failure Medicine Sacubitril/ Valsartan Granted NAFDAC Approval


Posted on: Tue 21-11-2017

Innovative heart failure medicine Sacubitril/ Valsartan first registered in the US in 2015; and with NAFDAC's approval, now accessible to patients in Nigeria for the treatment of heart failure with reduced ejection fraction (HFrEF)
 
Heart failure responsible for 50% of cardiovascular related sudden deaths in Nigeria; representing 35% of cardiovascular disease cases presented in teaching hospitals
 
Sacubitril/ Valsartan, first and only approved medicine of its kind, received top-class recommendation in the US and EU clinical guidelines for treatment of HFrEF.
 
Novartis product Sacubitril/ Valsartan, a breakthrough medicine for the treatment of heart failure (NYHA Class 11 - 1V) in patients with systolic dysfunction was approved by the National Agency for Food and Drug Administration and Control (NAFDAC) in August 2017. The product offers a significant improvement in the effectiveness of heart failure treatment versus current standard of care
 
This approval by NAFDAC is based on results from the landmark PARADIGM-HF study. The largest ever conducted in heart failure which showed Sacubitril/ Valsartan was superior to ACE-Inhibitor Enalapril on key endpoints including significantly reducing the risk of cardiovascular death or heart failure hospitalization whilst maintaining an acceptable safety profile. Patients reports of relief were also significantly better with Sacubitril/ Valsartan than with Enalapril
 
'Sacubitril/Valsartan is a demonstration of Novartis' commitment to discover new ways to improve the lives of patients;, said Dr Sunny Oyakhirome, Novartis Head of Medical Affairs - English West Africa
 
About Heart Failure in Nigeria
Heart failure is a debilitation and life threatening disease in which the heart cannot pump enough blood around the body. Symptoms of heart failure include breathlessness, fatigue and fluid retention among others. Available data suggest that heart failure is the cause of 50% of all cardiovascular-related sudden natural deaths in Nigeria and represents 35% of cardiovascular disease cases presented in Nigerian Teaching Hospitals. With one out of ten hospitalized heart failure patients dying. Millions of people worldwide live with heart failure and those seen in Nigerian hospitals are averagely 20 years younger compared to those in Europe and America. The estimated annual cost of heart failure care in Nigeria is USD 2,128 per patient, which is three times the minimum wage in the country.
 
Heart failure and its economic burden is a growing public health concern and consultant cardiologist Prof Anam Mbakwem said during the 2017 world Heart Day that 'Heart failure patients require four to five hospitalizations a year'
 
Heart failure costs the world economy $108 billion every year with hospitalizations comprising 60-70% of direct treatment costs
 
About Sacubitril/ VAlsartan in Heart Failure
Sacubitril/Valsartan is the first and only approved medicine of its kind. It is an oral medication with a unique mode of action designed to reduce the strain on a failing heart by enhancing the protective neuro-hormonal systems of the heart; and simultaneously suppressing the harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS). Sacubitril/ Valsartan has been given a top-class recommendation in the US and EU clinical guidelines for treatment of heart failure with reduced ejection fraction (HFrEF)
 
Disclaimer
This press release contains forward-looking statements with the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as 'can', 'further', 'commitment', 'discover', 'extend', 'developing', 'growing', 'designed to', or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labelling for the investigational or approved products described in this press release, or regarding potential future revenues from the product. You should not place undue reliance on these statements. Such forward-looking statements are based on our current belies and expectations 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, acutal results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally' our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; and general public pricing and reimbursement pressures; general economic and industry conditions including the effects of the persistently weak economic and financial environment in many countries; safety, quality or 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