Welcome!

News Feed Item

FDA Approves Piramal Imaging's Neuraceq™ (florbetaben F18 injection) for PET Imaging of Beta-Amyloid Neuritic Plaques in the Brain

BERLIN and BOSTON, March 20, 2014 /PRNewswire/ -- Piramal Imaging today announced that the U.S. Food and Drug Administration (FDA) has approved Neuraceq™. This approval comes only four weeks after receiving marketing authorization for Neuraceq™ from the European Commission.

http://www.piramal.com/imaging/ " border="0" alt=" http://www.piramal.com/imaging/ " align="middle" src="http://photos.prnewswire.com/prnvar/20140320/NE87281LOGO"/>

Neuraceq™ is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline.

There are an estimated 7.7 million new cases of dementia each year worldwide.1 Alzheimer's disease accounts for 60-80% of all dementia diagnoses.2 However, a clinical diagnosis of probable AD is incorrect upon post-mortem histological investigation in 10-30% of cases.3

The Centers for Medicare & Medicaid Services (CMS) has declared it will cover a beta-amyloid PET scan for patients under Coverage with Evidence Development (CED) programs. The objective of these programs is to assess the impact of beta-amyloid scans on improving patient outcomes or advancing patient treatment options.

"Alzheimer's disease or any form of cognitive impairment is a daunting diagnosis," said Dr. Ludger Dinkelborg, Director of the Board, Piramal Imaging. "For the patients and caregivers, the concern centers around understanding what the future holds. For physicians, the challenge is properly assessing the patient and determining the best care path."

"The FDA's approval of Neuraceq™ is a significant milestone for Piramal Imaging and demonstrates our dedication to advancing innovation in molecular imaging globally," said Dr. Swati Piramal, Vice Chairperson, Piramal Enterprises, Ltd. "The rising prevalence of Alzheimer's disease and cognitive impairment is being felt individually and collectively around the world. Our goal as a company is to usher in a new era of imaging that helps paint clearer pictures of the physiology of such conditions and helps improve patient outcomes."

The FDA approval of Neuraceq™ is based on safety data from 872 patients who participated in global clinical trials as well as three studies that examined images from adults with a range of cognitive function, including 205 end-of-life patients who had agreed to participate in a post-mortem brain donation program. Images were analyzed from 82 subjects with post-mortem confirmation of the presence or absence of beta-amyloid neuritic plaques. Correlation of the visual PET interpretation with histopathology in these 82 brains demonstrated that Neuraceq™ accurately detects moderate to frequent beta-amyloid neuritic plaques in the brain and is a useful tool to estimate the density of these plaques in life.

Piramal Imaging has partnered with IBA Molecular for manufacturing and distribution of Neuraceq™. IBA Molecular owns and operates a network of 49 PET isotope facilities worldwide, a network that is unique in both size and scope.

About Neuraceq™ (florbetaben F18 injection)

INDICATION


Neuraceq™ is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline.

A negative Neuraceq™ scan indicates sparse to no amyloid neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Neuraceq™ scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition.

Neuraceq™ is an adjunct to other diagnostic evaluations.

Limitations of Use

  • A positive Neuraceq™ scan does not establish the diagnosis of AD or any other cognitive disorder.
  • Safety and effectiveness of Neuraceq™ have not been established for:
    • Predicting development of dementia or other neurologic conditions;
    • Monitoring responses to therapies.

IMPORTANT SAFETY INFORMATION

Risk for Image Interpretation and Other Errors

Neuraceq™ can be used to estimate the density of beta-amyloid neuritic plaque deposition in the brain. Neuraceq™ is an adjunct to other diagnostic evaluations. Neuraceq™ images should be interpreted independent of a patient's clinical information. Physicians should receive training prior to interpretation of Neuraceq™ images. Following training, image reading errors (especially false positive) may still occur. Additional interpretation errors may occur due to, but not limited to, motion artifacts or extensive brain atrophy.

Radiation Risk

Administration of Neuraceq™, similar to other radiopharmaceuticals, contributes to a patient´s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. It is important to ensure safe handling to protect patients and health care workers from unintentional radiation exposure.

Most Common Adverse Reactions

In clinical trials, the most frequently observed adverse drug reactions in 872 subjects with 978 Neuraceq™ administrations were injection/application site erythema (1.7%), injection site irritation (1.2%), and injection site pain (3.9%).

About Piramal Imaging

Piramal Imaging, a division of Piramal Enterprises, Ltd., was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. By developing novel PET tracers for molecular imaging, Piramal Imaging is focusing on a key field of modern medicine. Piramal Imaging strives to be a leader in the Molecular Imaging field by developing innovative products that improve early detection and characterization of chronic and life threatening diseases, leading to better therapeutic outcomes and improved quality of life. For more information please go to www.piramal.com/imaging.

About Piramal Enterprises, Ltd.

Piramal Enterprises (PEL) is one of India's largest diversified companies, with a presence in pharmaceuticals, financial services and healthcare information management sectors. PEL had consolidated revenues of over $650 million in FY2013. In the pharmaceutical space, PEL is one of the leading custom manufacturing players globally, has presence in the global critical care segment with a portfolio of inhalation and injectable anesthetics and its OTC business is ranked no. 7 in India. PEL is also engaged in drug discovery and research, and has a strong pipeline of development products. In the financial services space, PEL has a real estate focused PE fund – Indiareit, and a NBFC that is focused on lending to the real estate and education sectors. PEL's healthcare information management business, Decision Resources Group, is a leading provider of information-based services to the healthcare industry.

1. WHO. Dementia: A public health priority; 2012
2. Alzheimer's Association. Alzheimer Dement. 2013;9
3. American Psychiatric Association. Practice guideline for the treatment of patients with Alzheimer's disease and other dementias. Second edition. 2007. http://psychiatryonline.org/content.aspx?bookid=28&sectionid=1679489#152139 (accessed 20 Dec 2011)

For media inquiries, please contact:

Emily Fisher - PR
Piramal Enterprises – Imaging Division
[email protected]

Akansha Pradhan
Corporate Communications
Piramal Group
Contact: +91 3351 4082
[email protected]

Logo - http://photos.prnewswire.com/prnh/20140320/NE87281LOGO

 

 

 

SOURCE Piramal Imaging

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
New Relic, Inc. has announced a set of new features across the New Relic Software Analytics Cloud that offer IT operations teams increased visibility, and the ability to diagnose and resolve performance problems quickly. The new features further IT operations teams’ ability to leverage data and analytics, as well as drive collaboration and a common, shared understanding between teams. Software teams are under pressure to resolve performance issues quickly and improve availability, as the comple...
The proper isolation of resources is essential for multi-tenant environments. The traditional approach to isolate resources is, however, rather heavyweight. In his session at 18th Cloud Expo, Igor Drobiazko, co-founder of elastic.io, will draw upon their own experience with operating a Docker container-based infrastructure on a large scale and present a lightweight solution for resource isolation using microservices. He will also discuss the implementation of microservices in data and applicat...
Join IBM June 8 at 18th Cloud Expo at the Javits Center in New York City, NY, and learn how to innovate like a startup and scale for the enterprise. You need to deliver quality applications faster and cheaper, attract and retain customers with an engaging experience across devices, and seamlessly integrate your enterprise systems. And you can't take 12 months to do it.
See storage differently! Storage performance problems have only gotten worse and harder to solve as applications have become largely virtualized and moved to a cloud-based infrastructure. Storage performance in a virtualized environment is not just about IOPS, it is about how well that potential performance is guaranteed to individual VMs for these apps as the number of VMs keep going up real time. In his session at 18th Cloud Expo, Dhiraj Sehgal, in product and marketing at Tintri, will discu...
Machine Learning helps make complex systems more efficient. By applying advanced Machine Learning techniques such as Cognitive Fingerprinting, wind project operators can utilize these tools to learn from collected data, detect regular patterns, and optimize their own operations. In his session at 18th Cloud Expo, Stuart Gillen, Director of Business Development at SparkCognition, will discuss how research has demonstrated the value of Machine Learning in delivering next generation analytics to im...
This is not a small hotel event. It is also not a big vendor party where politicians and entertainers are more important than real content. This is Cloud Expo, the world's longest-running conference and exhibition focused on Cloud Computing and all that it entails. If you want serious presentations and valuable insight about Cloud Computing for three straight days, then register now for Cloud Expo.
As you respond to increasing requests for new analytics, you need fast and flexible technology in your arsenal so that you can deploy the right workload to the right platform for the need at hand. Do you need self-service and fast time to value? Do you have data and application control and privacy needs, along with strict SLAs to meet? IBM dashDB™ is data warehouse technology powered by in-memory computing and in-database analytics that are designed for fast results, scalability and more.
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
So, you bought into the current machine learning craze and went on to collect millions/billions of records from this promising new data source. Now, what do you do with them? Too often, the abundance of data quickly turns into an abundance of problems. How do you extract that "magic essence" from your data without falling into the common pitfalls? In her session at @ThingsExpo, Natalia Ponomareva, Software Engineer at Google, will provide tips on how to be successful in large scale machine lear...
IoT device adoption is growing at staggering rates, and with it comes opportunity for developers to meet consumer demand for an ever more connected world. Wireless communication is the key part of the encompassing components of any IoT device. Wireless connectivity enhances the device utility at the expense of ease of use and deployment challenges. Since connectivity is fundamental for IoT device development, engineers must understand how to overcome the hurdles inherent in incorporating multipl...
Up until last year, enterprises that were looking into cloud services usually undertook a long-term pilot with one of the large cloud providers, running test and dev workloads in the cloud. With cloud’s transition to mainstream adoption in 2015, and with enterprises migrating more and more workloads into the cloud and in between public and private environments, the single-provider approach must be revisited. In his session at 18th Cloud Expo, Yoav Mor, multi-cloud solution evangelist at Cloudy...
We’ve worked with dozens of early adopters across numerous industries and will debunk common misperceptions, which starts with understanding that many of the connected products we’ll use over the next 5 years are already products, they’re just not yet connected. With an IoT product, time-in-market provides much more essential feedback than ever before. Innovation comes from what you do with the data that the connected product provides in order to enhance the customer experience and optimize busi...
The IETF draft standard for M2M certificates is a security solution specifically designed for the demanding needs of IoT/M2M applications. In his session at @ThingsExpo, Brian Romansky, VP of Strategic Technology at TrustPoint Innovation, will explain how M2M certificates can efficiently enable confidentiality, integrity, and authenticity on highly constrained devices.
The paradigm has shifted. A Gartner survey shows that 43% of organizations are using or plan to implement the Internet of Things in 2016. However, not just a handful of companies are still using the old-style ad-hoc trial-and-error ways, unaware of the critical barriers, paint points, traps, and hidden roadblocks. How can you become a winner? In his session at @ThingsExpo, Tony Shan will present a methodical approach to guide the holistic adoption and enablement of IoT implementations. This ov...