|By PR Newswire||
|March 15, 2014 09:05 AM EDT||
In the news release, U.S. FDA Accepts Veloxis' New Drug Application for Envarsus® for the Prevention of Organ Rejection in Kidney Transplant Patients, issued 13-Mar-2014 by Veloxis Pharmaceuticals, we are advised that the first bullet should read "FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of October 30, 2014" rather than "October 3, 2014" as originally issued inadvertently. The complete, corrected release follows:
U.S. FDA Accepts Veloxis' New Drug Application for Envarsus® for the Prevention of Organ Rejection in Kidney Transplant Patients
HORSHOLM, Denmark, March 13, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced the U.S. FDA accepted for standard review the company's New Drug Application (NDA) for Envarsus® for the prevention of organ rejection in adult kidney transplant patients. Envarsus® is Veloxis' once-daily tacrolimus based on the company's proprietary MELTDOSE technology.
- FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of October 30, 2014
- The NDA was submitted to the FDA on 30 December, 2013
- The NDA is based on two Phase III studies, 3001 and 3002, in which Envarsus demonstrated non-inferiority compared to twice daily tacrolimus (Prograf®) based on a composite endpoint of treatment failure at one year
- The clinical program comprised 25 studies and enrolled over 1,000 patients
- Envarsus is a once-daily formulation of tacrolimus that demonstrates a smoother pharmacokinetic profile and enables lower dosing to maintain therapeutic blood levels compared to twice-daily tacrolimus
- Envarsus received Orphan Drug Designation by the U.S. FDA for prophylaxis of organ rejection in patients receiving allogeneic kidney transplants
For more information, please contact:
Veloxis Pharmaceuticals A/S
John Weinberg, M.D.
EVP & Chief Operating Officer
Phone: +1 732 321 3208
Email: [email protected]
About Envarsus® (formerly LCP-Tacro™) and tacrolimus
Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. Envarsus® is an investigational drug that is being developed as a once daily tablet version of tacrolimus, with improved bioavailability, consistent pharmacokinetic performance and reduced peak to trough variability when compared to currently approved tacrolimus products. Transplant patients need to maintain a minimum blood level of tacrolimus for the prevention of transplant allograft rejection, but excessive levels may increase the risk of serious side effects such as nephrotoxicity, tremor, diabetes, high blood pressure, and opportunistic infections. Therefore, tacrolimus levels need to be managed carefully, and transplant patients are typically obliged to make frequent visits to the hospital for monitoring and dose adjustments after receiving a new organ.
About Veloxis Pharmaceuticals
Based in Horsholm, Denmark, with an office in New Jersey, Veloxis Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company. The company's lead product candidate is Envarsus® for immunosuppression, specifically organ transplantation. Veloxis' unique, patented delivery technology, MeltDose®, can improve absorption and bioavailability at low scale up costs. Veloxis has a lipid lowering product, Fenoglide®, currently on the U.S. market that is commercialized through partner Santarus, Inc. Veloxis is listed on the NASDAQ OMX Copenhagen under the trading symbol OMX: VELO.
For further information, please visit www.veloxis.com.
SOURCE Veloxis Pharmaceuticals
Organizations already struggle with the simple collection of data resulting from the proliferation of IoT, lacking the right infrastructure to manage it. They can't only rely on the cloud to collect and utilize this data because many applications still require dedicated infrastructure for security, redundancy, performance, etc. In his session at 17th Cloud Expo, Emil Sayegh, CEO of Codero Hosting, will discuss how in order to resolve the inherent issues, companies need to combine dedicated a...
Oct. 4, 2015 12:00 AM EDT Reads: 362
The modern software development landscape consists of best practices and tools that allow teams to deliver software in a near-continuous manner. By adopting a culture of automation, measurement and sharing, the time to ship code has been greatly reduced, allowing for shorter release cycles and quicker feedback from customers and users. Still, with all of these tools and methods, how can teams stay on top of what is taking place across their infrastructure and codebase? Hopping between services a...
Oct. 4, 2015 12:00 AM EDT Reads: 226
For almost two decades, businesses have discovered great opportunities to engage with customers and even expand revenue through digital systems, including web and mobile applications. Yet, even now, the conversation between the business and the technologists that deliver these systems is strained, in large part due to misaligned objectives. In his session at DevOps Summit, James Urquhart, Senior Vice President of Performance Analytics at SOASTA, Inc., will discuss how measuring user outcomes –...
Oct. 3, 2015 11:00 PM EDT Reads: 267
Clearly the way forward is to move to cloud be it bare metal, VMs or containers. One aspect of the current public clouds that is slowing this cloud migration is cloud lock-in. Every cloud vendor is trying to make it very difficult to move out once a customer has chosen their cloud. In his session at 17th Cloud Expo, Naveen Nimmu, CEO of Clouber, Inc., will advocate that making the inter-cloud migration as simple as changing airlines would help the entire industry to quickly adopt the cloud wit...
Oct. 3, 2015 09:00 PM EDT Reads: 339
While testing is often ignored when it comes to DevOps - it could be the most important aspect of achieving true DevOps success. Without rethinking automated testing from the ground-up, the entire DevOps productivity gain cannot be realized. Large tech companies build their own rapid test automation that runs in minutes across functional, performance, security and other tests. In his session at DevOps Summit, Kevin Surace, CEO of Appvance, will discuss how we learn from these real-world succe...
Oct. 3, 2015 06:00 PM EDT Reads: 287
SYS-CON Events announced today that VividCortex, the monitoring solution for the modern data system, will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. The database is the heart of most applications, but it’s also the part that’s hardest to scale, monitor, and optimize even as it’s growing 50% year over year. VividCortex is the first unified suite of database monitoring tools specifically desi...
Oct. 3, 2015 05:00 PM EDT Reads: 305
Apps and devices shouldn't stop working when there's limited or no network connectivity. Learn how to bring data stored in a cloud database to the edge of the network (and back again) whenever an Internet connection is available. In his session at 17th Cloud Expo, Bradley Holt, Developer Advocate at IBM Cloud Data Services, will demonstrate techniques for replicating cloud databases with devices in order to build offline-first mobile or Internet of Things (IoT) apps that can provide a better, ...
Oct. 3, 2015 05:00 PM EDT Reads: 312
Interested in leveraging automation technologies and a cloud architecture to make developers more productive? Learn how PaaS can benefit your organization to help you streamline your application development, allow you to use existing infrastructure and improve operational efficiencies. Begin charting your path to PaaS with OpenShift Enterprise.
Oct. 3, 2015 03:00 PM EDT Reads: 260
“All our customers are looking at the cloud ecosystem as an important part of their overall product strategy. Some see it evolve as a multi-cloud / hybrid cloud strategy, while others are embracing all forms of cloud offerings like PaaS, IaaS and SaaS in their solutions,” noted Suhas Joshi, Vice President – Technology, at Harbinger Group, in this exclusive Q&A with Cloud Expo Conference Chair Roger Strukhoff.
Oct. 3, 2015 03:00 PM EDT Reads: 265
SYS-CON Events announced today that Agema Systems will exhibit at the 17th International Cloud Expo®, which will take place on November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Agema Systems is the leading provider of critical white-box rack solutions to data centers through the major integrators and value added distribution channels.
Oct. 3, 2015 02:15 PM EDT Reads: 545
SYS-CON Events announced today that Cloud Raxak has been named “Media & Session Sponsor” of SYS-CON's 17th Cloud Expo, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Raxak Protect automates security compliance across private and public clouds. Using the SaaS tool or managed service, developers can deploy cloud apps quickly, cost-effectively, and without error.
Oct. 3, 2015 01:15 PM EDT Reads: 558
DevOps is gaining traction in the federal government – and for good reasons. Heightened user expectations are pushing IT organizations to accelerate application development and support more innovation. At the same time, budgetary constraints require that agencies find ways to decrease the cost of developing, maintaining, and running applications. IT now faces a daunting task: do more and react faster than ever before – all with fewer resources.
Oct. 3, 2015 01:00 PM EDT Reads: 243
SYS-CON Events announced today that ProfitBricks, the provider of painless cloud infrastructure, will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. ProfitBricks is the IaaS provider that offers a painless cloud experience for all IT users, with no learning curve. ProfitBricks boasts flexible cloud servers and networking, an integrated Data Center Designer tool for visual control over the...
Oct. 3, 2015 01:00 PM EDT Reads: 641
SYS-CON Events announced today that Key Information Systems, Inc. (KeyInfo), a leading cloud and infrastructure provider offering integrated solutions to enterprises, will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Key Information Systems is a leading regional systems integrator with world-class compute, storage and networking solutions and professional services for the most advanced softwa...
Oct. 3, 2015 12:45 PM EDT Reads: 222
Mobile messaging has been a popular communication channel for more than 20 years. Finnish engineer Matti Makkonen invented the idea for SMS (Short Message Service) in 1984, making his vision a reality on December 3, 1992 by sending the first message ("Happy Christmas") from a PC to a cell phone. Since then, the technology has evolved immensely, from both a technology standpoint, and in our everyday uses for it. Originally used for person-to-person (P2P) communication, i.e., Sally sends a text...
Oct. 3, 2015 12:00 PM EDT Reads: 132