Rapiscan(R) (regadenoson) is the First Selective A2A Adenosine Receptor Agonist to Receive EU Commission Licence to Aid CAD Diagnosis
By Rapidscan Pharma Solutions, PRNETuesday, January 25, 2011
LONDON, January 26, 2011 - Today Rapidscan Pharma Solutions (RPS) EU Ltd announced it has received
marketing authorization for Rapiscan(R) (regadenoson) - a selective coronary
vasodilator for use as a pharmacological stress agent in the diagnosis of
coronary artery disease (CAD) - the single most common cause of death and
disability in Europe[1]. Rapiscan is administered as a non-weight based bolus
injection and is the first and only selective A2A adenosine receptor agonist
to have a licence for use in this indication.
Diagnosis of CAD uses Myocardial Perfusion Imaging (MPI) to identify
areas of poor blood flow in the heart at rest and during exercise. Patients
are commonly asked to exercise on a treadmill or bicycle, however nearly half
of all patients are unable to exercise adequately. Rapiscan simulates the
effects of exercise by temporarily increasing blood flow through the arteries
of the heart, providing an option for such patients. Unlike older agents,
Rapiscan requires no dose adjustment for varying body weight[2] and its bolus
dosing method is rapid (taking just 10 seconds), cutting out the need for an
infusion pump and its set-up.
Founder, President and CEO of Rapidscan Pharma Solutions Dr Brent
Blackburn commented, "I am extremely excited to bring Rapiscan to
Europe. Rapiscan was designed to specifically address the needs of patients
and healthcare professionals who conduct MPI tests. It's easier to use and
better tolerated than the older agents."
Every year more than 4 million Europeans die from diseases of the heart
and blood vessel[1], accounting for almost half of total mortality in
Europe1. Accurate diagnosis is vital in identifying patients who are
appropriate for intensive medical intervention with more than 1.5 million
Europeans undergoing MPI tests annually.
Regadenoson was launched in the US in 2008 following clinical trials of
over 2,000 patients with known or suspected CAD[3,4]. Today, regadenoson is
currently the most widely used pharmacological stress agent in the US with
more than 3 million patients having received it.
Notes to Editors:
More about regadenoson
Regadenoson is a selective A2A adenosine receptor agonist approved as a
pharmacological stress agent in radionuclide MPI, in patients unable to
undergo adequate exercise stress testing. Regadenoson was discovered and
developed by CV Therapeutics and was approved by the FDA in April 2008 and
received EU Commission License by the European Medicine Agency in September
2010.
About Rapidscan Pharma Solutions (RPS)
U.S.-based Rapidscan Pharma Solutions Inc was established in 2010 by its
President and CEO Dr Brent Blackburn. In September 2010 RPS Inc licensed the
rights to develop, make, and sell regadenoson from Gilead Sciences Inc for
Europe, Japan, Australia, New Zealand, and Israel. Its European affiliate,
RPS EU Ltd is responsible for marketing regadenoson in Europe. Dr Blackburn
was previously with CV Therapeutics and was a leading member of the team that
discovered and developed regadenoson in the U.S. and Europe.
References:
1. Scholte op Reimer WJM, Gitt AK, Boersma E, Simoons ML (eds.).
Cardiovascular Diseases in Europe. Euro Heart Survey - 2006. Sophia
Antipolis; European Society of Cardiology; 2006
2. Rapiscan Summary of Product Characteristics. Gilead Sciences;
September 2010. See
www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001176/human_med_001378.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d125
3. Cerqueira MD, Nguyen P, Staehr P, et al, on behalf of the ADVANCE MPI
Trial Investigators. Effects of age, gender, obesity and diabetes on the
efficacy and safety of the selective A2A agonist Rapiscan versus adenosine:
integrated ADVANCE MPI trial results. J Am Coll Cardiol 2008;1:307–?316.
4. Iskandrian AE, Bateman TM, Belardinelli L, et al. Adenosine versus
Rapiscan comparative evaluation in myocardial perfusion imaging: results of
the ADVANCE phase 3 multicenter international trial. J Nucl Cardiol
2007;14:645-658.
For further media enquiries please contact: Nicola Kent, Packer Forbes Communications, +44(0)20-7036-8550, nicola at packerforbes.com; All other enquiries: Brent Blackburn, PhD, President & CEO, Rapidscan Pharma Solutions Inc, +1-650-776-1198, brent.blackburn at rapidscanpharma.com
Tags: January 26, London, Rapidscan Pharma Solutions, United Kingdom