Welcome!

News Feed Item

FDA Advisory Committee Recommends Approval of Tiotropium Respimat® for the Maintenance Treatment of COPD

Committee Voted Based on Clinical Data from Eight Efficacy Trials

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.

About COPD
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.

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
DX World EXPO, LLC, a Lighthouse Point, Florida-based startup trade show producer and the creator of "DXWorldEXPO® - Digital Transformation Conference & Expo" has announced its executive management team. The team is headed by Levent Selamoglu, who has been named CEO. "Now is the time for a truly global DX event, to bring together the leading minds from the technology world in a conversation about Digital Transformation," he said in making the announcement.
"Space Monkey by Vivent Smart Home is a product that is a distributed cloud-based edge storage network. Vivent Smart Home, our parent company, is a smart home provider that places a lot of hard drives across homes in North America," explained JT Olds, Director of Engineering, and Brandon Crowfeather, Product Manager, at Vivint Smart Home, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that Conference Guru has been named “Media Sponsor” of the 22nd International Cloud Expo, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organizers to pass great deals to gre...
DevOps is under attack because developers don’t want to mess with infrastructure. They will happily own their code into production, but want to use platforms instead of raw automation. That’s changing the landscape that we understand as DevOps with both architecture concepts (CloudNative) and process redefinition (SRE). Rob Hirschfeld’s recent work in Kubernetes operations has led to the conclusion that containers and related platforms have changed the way we should be thinking about DevOps and...
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and shared the must-have mindsets for removing complexity from the develop...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
The next XaaS is CICDaaS. Why? Because CICD saves developers a huge amount of time. CD is an especially great option for projects that require multiple and frequent contributions to be integrated. But… securing CICD best practices is an emerging, essential, yet little understood practice for DevOps teams and their Cloud Service Providers. The only way to get CICD to work in a highly secure environment takes collaboration, patience and persistence. Building CICD in the cloud requires rigorous ar...
Companies are harnessing data in ways we once associated with science fiction. Analysts have access to a plethora of visualization and reporting tools, but considering the vast amount of data businesses collect and limitations of CPUs, end users are forced to design their structures and systems with limitations. Until now. As the cloud toolkit to analyze data has evolved, GPUs have stepped in to massively parallel SQL, visualization and machine learning.
"Evatronix provides design services to companies that need to integrate the IoT technology in their products but they don't necessarily have the expertise, knowledge and design team to do so," explained Adam Morawiec, VP of Business Development at Evatronix, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
To get the most out of their data, successful companies are not focusing on queries and data lakes, they are actively integrating analytics into their operations with a data-first application development approach. Real-time adjustments to improve revenues, reduce costs, or mitigate risk rely on applications that minimize latency on a variety of data sources. In his session at @BigDataExpo, Jack Norris, Senior Vice President, Data and Applications at MapR Technologies, reviewed best practices to ...
Widespread fragmentation is stalling the growth of the IIoT and making it difficult for partners to work together. The number of software platforms, apps, hardware and connectivity standards is creating paralysis among businesses that are afraid of being locked into a solution. EdgeX Foundry is unifying the community around a common IoT edge framework and an ecosystem of interoperable components.
"ZeroStack is a startup in Silicon Valley. We're solving a very interesting problem around bringing public cloud convenience with private cloud control for enterprises and mid-size companies," explained Kamesh Pemmaraju, VP of Product Management at ZeroStack, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Large industrial manufacturing organizations are adopting the agile principles of cloud software companies. The industrial manufacturing development process has not scaled over time. Now that design CAD teams are geographically distributed, centralizing their work is key. With large multi-gigabyte projects, outdated tools have stifled industrial team agility, time-to-market milestones, and impacted P&L stakeholders.
"Akvelon is a software development company and we also provide consultancy services to folks who are looking to scale or accelerate their engineering roadmaps," explained Jeremiah Mothersell, Marketing Manager at Akvelon, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Enterprises are adopting Kubernetes to accelerate the development and the delivery of cloud-native applications. However, sharing a Kubernetes cluster between members of the same team can be challenging. And, sharing clusters across multiple teams is even harder. Kubernetes offers several constructs to help implement segmentation and isolation. However, these primitives can be complex to understand and apply. As a result, it’s becoming common for enterprises to end up with several clusters. Thi...