|By PR Newswire||
|August 14, 2014 04:36 PM EDT||
RIDGEFIELD, Conn., Aug. 14, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted [10 yes, 3 no] that existing data supports approval of Boehringer Ingelheim's investigational tiotropium bromide inhalation spray for long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. If approved by the FDA, the proposed proprietary name for tiotropium bromide inhalation spray will be Spiriva® Respimat®.
The Advisory Committee voted that existing data supports approval after a review of the results from eight efficacy clinical trials in which 8,700 patients were treated with tiotropium in the RESPIMAT inhaler. One of these trials, TIOSPIR™, the largest clinical trial conducted to date in patients with COPD, collected data from more than 17,000 COPD patients from 50 countries.
"As a practicing physician, it's essential to have multiple treatment choices available when assessing how to help people affected by this devastating disease," said Stephen Rennard, M.D., Professor, Internal Medicine, Division of Pulmonary, Critical Care, Sleep & Allergy, University of Nebraska Medical Center.
The Advisory Committee provides non-binding recommendations for consideration by the FDA, which makes the final decision on approval.
"We are pleased with the endorsement from PADAC members, and recommendation of approval for tiotropium RESPIMAT in the U.S.," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "At Boehringer Ingelheim, we have been committed to discovering and developing new treatments to help people affected by COPD for several decades. If approved, tiotropium RESPIMAT would build upon our heritage in treating respiratory diseases by equipping healthcare providers and their patients with an important new treatment option."
RESPIMAT is a multi-dose, propellant-free inhaler that uses mechanical energy to generate a slow-moving mist to deliver tiotropium, the same active ingredient as Spiriva® HandiHaler® (tiotropium bromide inhalation powder). If approved, tiotropium RESPIMAT would provide physicians and their patients with a choice between a mist and dry powder inhaler for tiotropium.
The availability and continued use of SPIRIVA HandiHaler is not affected by the Advisory Committee vote or subsequent FDA decision. SPIRIVA HandiHaler has an established efficacy and safety profile based on 29 placebo controlled clinical trials in over 12,000 patients.
About Spiriva® HandiHaler® (tiotropium bromide inhalation powder)
SPIRIVA HandiHaler is a prescription medicine used once every day (a maintenance medicine) to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing airways. COPD includes chronic bronchitis, emphysema or both.
SPIRIVA HandiHaler also reduces the likelihood of flare-ups (COPD exacerbations), which are new or worsening of symptoms in patients with COPD.
Important Safety Information for Spiriva HandiHaler (tiotropium bromide inhalation powder)
SPIRIVA HandiHaler (tiotropium bromide inhalation powder) is contraindicated in patients with a history of hypersensitivity to tiotropium, ipratropium (atropine derivatives), or any components of SPIRIVA capsules.
SPIRIVA HandiHaler is not indicated for the initial treatment of acute episodes of bronchospasm, i.e., rescue therapy.
Immediate hypersensitivity reactions, including urticaria, angioedema (swelling of lips, tongue or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of SPIRIVA HandiHaler. Additionally, inhaled medicines, including SPIRIVA HandiHaler, may cause paradoxical bronchospasm. If any of these occurs, treatment with SPIRIVA HandiHaler should be stopped and other treatments considered.
Patients with a history of hypersensitivity reactions to atropine should be closely monitored for similar hypersensitivity reactions to SPIRIVA HandiHaler.
Use with caution in patients with severe hypersensitivity to milk proteins.
SPIRIVA HandiHaler should be used with caution in patients with narrow-angle glaucoma or urinary retention. Prescribers should instruct patients to consult a physician immediately should any signs or symptoms of narrow-angle glaucoma, or prostatic hyperplasia or bladder-neck obstruction occur.
Since dizziness and blurred vision may occur with the use of SPIRIVA HandiHaler, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery.
As SPIRIVA HandiHaler is a predominantly renally excreted drug, SPIRIVA HandiHaler use should be monitored closely in patients with moderate to severe renal impairment (creatinine clearance of ≤ 50 mL/min).
SPIRIVA HandiHaler has been used concomitantly with short-acting and long-acting sympathomimetic (beta-agonists) bronchodilators, methylxanthines, and oral and inhaled steroids without increases in adverse drug reactions.
SPIRIVA HandiHaler may interact additively with concomitantly used anticholinergic medications. Avoid coadministration with other anticholinergic-containing drugs.
The most common adverse reactions in the 1-year placebo-controlled trials were dry mouth, upper respiratory tract infection, sinusitis, pharyngitis, non-specific chest pain, and urinary tract infection. In addition, the most commonly reported adverse reactions from the 4-year trial not included above were headache, constipation, depression, insomnia, and arthralgia.
SPIRIVA capsules should not be swallowed and should only be inhaled through the mouth (oral inhalation) using the HandiHaler device. The HandiHaler device should not be used for administering other medications.
SPIRIVA capsules should always be stored in the sealed blisters, and only removed immediately before use, or else its effectiveness may be reduced.
Please refer to the Instructions for Use for additional information on the use of SPIRIVA HandiHaler.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For full prescribing information, please visit www.spiriva.com, or call 1-800-542-6257 option #4.
Click here for full Spiriva Prescribing Information, Patient Information and Instructions for Use.
Chronic obstructive pulmonary disease (COPD) is a term including chronic bronchitis and/or emphysema. This disease can make breathing harder because less air is able to flow in and out of the lungs. Chronic lower respiratory diseases, which include COPD, are the third leading cause of death in the United States, and approximately 15 million Americans have been told by a healthcare provider that they have COPD.
The most common symptom of COPD is shortness of breath, especially with physical activities. Coughing, with or without mucus production, is also a common symptom of COPD. These symptoms can be misunderstood as signs of aging. COPD is usually associated with progressive airway damage and loss that cause breathing to get more difficult.
Leading respiratory forward
Through research, Boehringer Ingelheim (BI) has developed drug therapies to help patients with lung diseases. Leveraging the company's cutting edge science and leadership in chronic obstructive pulmonary disease (COPD), BI is researching new treatment approaches where needs persist. It is the company's goal to help patients with COPD, asthma, lung cancer, and idiopathic pulmonary fibrosis.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates and more than 47,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
Social responsibility is a central element of Boehringer Ingelheim's culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.
In 2013, Boehringer Ingelheim achieved net sales of about $18.7 billion (14.1 billion euro). R&D expenditure in the Prescription Medicines business corresponds to 19.5% of its net sales.
For more information please visit http://www.us.boehringer-ingelheim.com.
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Am...
Aug. 27, 2016 02:45 PM EDT Reads: 3,437
I wanted to gather all of my Internet of Things (IOT) blogs into a single blog (that I could later use with my University of San Francisco (USF) Big Data “MBA” course). However as I started to pull these blogs together, I realized that my IOT discussion lacked a vision; it lacked an end point towards which an organization could drive their IOT envisioning, proof of value, app dev, data engineering and data science efforts. And I think that the IOT end point is really quite simple…
Aug. 27, 2016 12:45 PM EDT Reads: 2,331
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - comp...
Aug. 27, 2016 12:30 PM EDT Reads: 3,608
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Aug. 27, 2016 12:00 PM EDT Reads: 480
SYS-CON Events announced today that eCube Systems, a leading provider of middleware modernization, integration, and management solutions, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. eCube Systems offers a family of middleware evolution products and services that maximize return on technology investment by leveraging existing technical equity to meet evolving business needs. ...
Aug. 27, 2016 12:00 PM EDT Reads: 621
StarNet Communications Corp has announced the addition of three Secure Remote Desktop modules to its flagship X-Win32 PC X server. The new modules enable X-Win32 to safely tunnel the remote desktops from Linux and Unix servers to the user’s PC over encrypted SSH. Traditionally, users of PC X servers deploy the XDMCP protocol to display remote desktop environments such as the Gnome and KDE desktops on Linux servers and the CDE environment on Solaris Unix machines. XDMCP is used primarily on comp...
Aug. 27, 2016 12:00 PM EDT Reads: 626
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportuni...
Aug. 27, 2016 11:00 AM EDT Reads: 3,964
DevOps at Cloud Expo, taking place Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long dev...
Aug. 27, 2016 11:00 AM EDT Reads: 2,347
Aspose.Total for .NET is the most complete package of all file format APIs for .NET as offered by Aspose. It empowers developers to create, edit, render, print and convert between a wide range of popular document formats within any .NET, C#, ASP.NET and VB.NET applications. Aspose compiles all .NET APIs on a daily basis to ensure that it contains the most up to date versions of each of Aspose .NET APIs. If a new .NET API or a new version of existing APIs is released during the subscription peri...
Aug. 27, 2016 10:30 AM EDT Reads: 1,958
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Aug. 27, 2016 10:15 AM EDT Reads: 1,892
SYS-CON Events announced today that StarNet Communications will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. StarNet Communications’ FastX is the industry first cloud-based remote X Windows emulator. Using standard Web browsers (FireFox, Chrome, Safari, etc.) users from around the world gain highly secure access to applications and data hosted on Linux-based servers in a central data center. ...
Aug. 27, 2016 08:45 AM EDT Reads: 759
SYS-CON Events announced today that Hitrons Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Hitrons Solutions Inc. is distributor in the North American market for unique products and services of small and medium-size businesses, including cloud services and solutions, SEO marketing platforms, and mobile applications.
Aug. 27, 2016 08:00 AM EDT Reads: 607
As the world moves toward more DevOps and Microservices, application deployment to the cloud ought to become a lot simpler. The Microservices architecture, which is the basis of many new age distributed systems such as OpenStack, NetFlix and so on, is at the heart of Cloud Foundry - a complete developer-oriented Platform as a Service (PaaS) that is IaaS agnostic and supports vCloud, OpenStack and AWS. Serverless computing is revolutionizing computing. In his session at 19th Cloud Expo, Raghav...
Aug. 27, 2016 07:45 AM EDT Reads: 792
Pulzze Systems was happy to participate in such a premier event and thankful to be receiving the winning investment and global network support from G-Startup Worldwide. It is an exciting time for Pulzze to showcase the effectiveness of innovative technologies and enable them to make the world smarter and better. The reputable contest is held to identify promising startups around the globe that are assured to change the world through their innovative products and disruptive technologies. There w...
Aug. 27, 2016 07:45 AM EDT Reads: 669
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
Aug. 27, 2016 03:15 AM EDT Reads: 1,782