Daiichi Sankyo and Eli Lilly and Company: Heart patients in England and Wales offered more choice of therapies as NICE extends recommendations for prasugrel
GERRARDS CROSS, England, Jul 23, 2014 (BUSINESS WIRE) -- Revised guidance from the National Institute for Health and Care Excellence (NICE), recommends once-daily, oral antiplatelet prasugrel (Efient®), in combination with aspirin, as a cost-effective option when compared to generic clopidogrel, for a wider group of acute coronary syndrome (ACS) patients having primary or delayed percutaneous coronary intervention (PCI).1
Prasugrel, will now also be available for preventing atherothrombotic events for adults with ACS with unstable angina (UA) or non-ST-segment elevation myocardial infarction (NSTEMI) having PCI.1 This latest recommendation builds on initial NICE guidance in October 2009, which recommended prasugrel for ACS patients having PCI when immediate primary PCI for ST-segment elevation myocardial infarction (STEMI) is necessary, or when stent thrombosis has occurred during clopidogrel treatment, or if the patient has diabetes mellitus.2
Dr Tim Kinnaird, Consultant Cardiologist at University College Cardiff, who acted as an adviser to the NICE appraisal committee said: "This recommendation is very welcome as it offers clinicians a wider choice to protect ACS patients against atherothrombotic events when undergoing PCI. It is important that all suitable treatment options are available so the most appropriate clinical decision to manage patients can be made particularly for higher-risk patients with other co-morbidities, such as diabetes. Having another cost effective option for UA and NSTEMI patients undergoing PCI is particularly relevant to the UK, as this patient population is generally treated poorly compared to STEMI patients undergoing PCI."
The NICE Assessment Group reported that the TRITON-TIMI 38 trial (comparing prasugrel with clopidogrel in 13,608 patients with moderate- to high-risk ACS scheduled to have PCI), was robustly designed and of strong methodological quality. For patients in the core clinical cohort (younger than 75 years, weighing 60 kg or more and with no history of stroke or transient ischaemic attack), prasugrel demonstrated a clinically significant and robust reduction in the primary end point compared with clopidogrel.1
Dr Jean-Michel Cosséry, Vice President & Managing Director – Lilly UK and Northern Europe said: "We welcome this recognition from NICE that prasugrel is a cost effective option when compared to generic clopidogrel. The extended guidance means that both STEMI and NSTEMI patients can benefit from this effective treatment."
"We welcome this latest recommendation from NICE and the assessment is based on the strong clinical trial data for prasugrel demonstrating efficacy across all subgroups," said Dr Simon Clough, Managing Director of Daiichi Sankyo UK. "We are glad that NSTEMI and UA patients in England and Wales will have another therapy option and this latest decision now puts England and Wales in line with the health and policy recommendations for prasugrel in other European countries."
Daiichi Sankyo Company, Limited, and Eli Lilly and Company co-developed prasugrel, an oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries, Ltd. Prasugrel inhibits platelets from sticking together and prevents arterial thrombosis. The European Commission granted marketing authorisation for prasugrel for the prevention of atherothrombotic events in patients with acute coronary syndrome (ACS) undergoing PCI (stenting), in combination with aspirin, in 2009. To date prasugrel has been approved for use in more than 65 countries worldwide, including within the EU, UK, France, Germany, Italy, Spain and Ireland.
About acute coronary syndrome (ACS)
ACS refers to any group of symptoms attributed to obstruction of the coronary arteries. The most common symptom prompting diagnosis of ACS is chest pain, often radiating to the left arm or angle of the jaw, pressure-like in character, and associated with nausea and sweating. Acute coronary syndrome occurs as: ST elevation myocardial infarction (STEMI), non ST elevation myocardial infarction (NSTEMI), or unstable angina (UA).
Of the hospital admissions with a final diagnosis of myocardial infarction (MI) recorded between April 2012 and March 2013 in the Myocardial Ischaemia National Audit Project (MINAP), around 40% have been identified as STEMI, where the coronary artery is typically completely blocked, while the remaining 60% are classified as NSTEMI, where it is partially blocked.1 STEMI heart attacks are often considered more severe as the artery is often fully blocked, preventing blood flow to the heart muscle.
Coronary heart disease (CHD) is the single most common cause of death in the European Union, accounting for more than 681,000 deaths in the EU each year including over 82,000 in the UK alone.3
There are an estimated 32,000 hospital admissions for UA and around 82,000 cases of MI yearly in the UK.The average age of people with STEMI and NSTEMI is 65 years and 72 years respectively. Twice as many men as women are believed to be at risk of an MI.1
Patients with STEMI typically receive antiplatelet treatment as early as possible after the onset of symptoms and are then immediately scheduled for urgent revascularisation (in most cases percutaneous coronary intervention (PCI)). The diagnosis and treatment approach for NSTEMI patients is more complex and requires specialist assessment.
Many ACS patients undergo PCI to re-open the artery, which usually includes a stent placement. The PCI procedure manually opens up arteries to restore healthy blood flow to the heart muscle.4 Patients with ACS who undergo PCI with stenting are usually treated with aspirin for their lifetime and another oral antiplatelet treatment (such as prasugrel) for a year after their procedure to prevent the formation of blood clots and the occurrence of additional ACS events.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.co.uk .
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, dyslipidaemia and bacterial infections used by patients around the world, the Group has also launched treatments for thrombotic disorders and is building new product franchises.
Furthermore, Daiichi Sankyo research and development is focused on bringing forth novel therapies in oncology and cardiovascular-metabolic diseases, including biologics.
The Daiichi Sankyo Group has created a "Hybrid Business Model," to respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit: www.daiichisankyo.com .
This press release contains certain forward-looking statements about prasugrel in acute coronary syndrome NSTEMI patients and reflects Daiichi Sankyo's and Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that the product will meet our commercial expectations. For further discussion of these and other risks and uncertainties, see Lilly's filing with the United States Securities and Exchange Commission and Daiichi Sankyo's filings with the Tokyo Stock Exchange. Daiichi Sankyo and Lilly undertake no duty to update forward-looking statements.
Efient® is a registered trademark of Eli Lilly and Company.
1. NICE. Prasugrel with percutaneous coronary intervention for treating acute coronary syndromes (review of technology appraisal guidance 182). Technology appraisal 317. London: NICE; July 2014. ( www.nice.org.uk )
2. NICE. Prasugrel for the treatment of acute coronary syndromes with percutaneous coronary intervention Technology appraisal 182. London: NICE; October 2009. ( www.nice.org.uk )
3. British Heart Foundation Health Promotion Research Group. European Cardiovascular Disease Statistics 2012
4. Coronary angioplasty and stent insertion. NHS Choices. Available here: http://www.nhs.uk/Conditions/Coronary-angioplasty/Pages/Introduction.aspx . Last accessed July 2014
SOURCE: Daiichi Sankyo Company, Limited, and Eli Lilly and Company