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Boehringer Ingelheim Pharmaceuticals, Inc. Announces U.S. Filing For The Fixed-Dose Combination Tiotropium Plus Olodaterol For Patients With COPD


8/19/2014 8:14:39 AM

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RIDGEFIELD, Conn., Aug. 19, 2014 /PRNewswire/ -- Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for the fixed-dose combination (FDC) of tiotropium and olodaterol delivered via the Respimat® inhaler for the proposed indication of long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Tiotropium + olodaterol FDC will not be indicated to treat acute deteriorations of COPD or to treat asthma.

Tiotropium + olodaterol FDC is an investigational treatment consisting of the long-acting muscarinic antagonist (LAMA) tiotropium and the long-acting beta agonist (LABA) olodaterol, and is being evaluated for once-daily use via the Respimat® inhaler. The Respimat® inhaler is a propellant-free inhaler that generates a slow-moving mist.

"The FDA's acceptance of our application for the fixed-dose combination of tiotropium and olodaterol is an important milestone for our company, and it reinforces Boehringer Ingelheim's steadfast commitment to COPD," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc.

The NDA submission for tiotropium + olodaterol FDC is based on results from three global Phase III trials the 52-week replicate TONADO® 1&2 studies (NCT01431274/NCT01431287) and the 6-week cross-over VIVACITO® study (NCT01559116). The TONADO® 1&2 studies evaluated the long-term effect of tiotropium + olodaterol FDC on lung function, while VIVACITO® investigated the 24-hour bronchodilator profile of two tiotropium + olodaterol dose combinations. These studies are part of a large Phase III clinical trial program (TOviTO®) for tiotropium + olodaterol FDC, which includes more than 7,000 people living with varying severities of COPD worldwide.

Tiotropium monotherapy, which is marketed as Spiriva® HandiHaler® (tiotropium bromide inhalation powder) in the U.S., is a once-daily LAMA indicated for both the maintenance treatment of bronchospasm (narrowing of the airways) associated with COPD and to reduce COPD exacerbations. Olodaterol monotherapymarketed as Striverdi® Respimat® (olodaterol) Inhalation Sprayis a once-daily LABA indicated for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.

Important Safety Information for Spiriva® HandiHaler® (tiotropium bromide inhalation powder)
SPIRIVA HandiHaler 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 narrowangle glaucoma or urinary retention. Prescribers should instruct patients to consult a physician immediately should any signs or symptoms of narrowangle glaucoma, or prostatic hyperplasia or bladderneck 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 less than or equal to 50 mL/min).

SPIRIVA HandiHaler has been used concomitantly with shortacting and longacting sympathomimetic (betaagonists) 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 anticholinergiccontaining drugs.

The most common adverse reactions in the 1year placebocontrolled trials were dry mouth, upper respiratory tract infection, sinusitis, pharyngitis, nonspecific chest pain, and urinary tract infection. In addition, the most commonly reported adverse reactions from the 4year 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.

Indication
SPIRIVA® HandiHaler® (tiotropium bromide inhalation powder) is indicated for the longterm, oncedaily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for reducing COPD exacerbations. 

Click here for full SPIRIVA HandiHaler Prescribing Information, Patient Information, and Instructions for Use.

Important Safety Information for Striverdi® Respimat® (olodaterol) Inhalation Spray

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large, placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including olodaterol, the active ingredient in STRIVERDI RESPIMAT.  The safety and efficacy of STRIVERDI RESPIMAT in patients with asthma have not been established.  STRIVERDI RESPIMAT is not indicated for the treatment of asthma.

All LABA are contraindicated in patients with asthma without use of a long-term asthma control medication.

STRIVERDI RESPIMAT should not be initiated in patients with acutely deteriorating COPD, which may be a life threatening condition, or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2 agonist.

STRIVERDI RESPIMAT should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medications containing long-acting beta2 agonists as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.

STRIVERDI RESPIMAT may produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, STRIVERDI RESPIMAT should be discontinued immediately and alternative therapy instituted.

STRIVERDI RESPIMAT can produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate, systolic or diastolic blood pressure, or symptoms, and should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy, and hypertension.  If cardiovascular symptoms occur, STRIVERDI RESPIMAT may need to be discontinued. 

STRIVERDI RESPIMAT should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, in patients with known or suspected prolongation of the QT interval, and in patients who are unusually responsive to sympathomimetic amines.

Immediate hypersensitivity reactions, including angioedema, may occur.  If such a reaction occurs, therapy with STRIVERDI RESPIMAT should be stopped at once and alternative treatment should be considered.

The most commonly reported adverse reactions were nasopharyngitis, upper respiratory tract infection, bronchitis, urinary tract infection, cough, dizziness, rash, diarrhea, back pain, and arthralgia.

STRIVERDI RESPIMAT should be used with extreme caution in patients treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated.

STRIVERDI RESPIMAT should be used with caution in patients treated with additional adrenergic drugs, non-potassium-sparing diuretics, and beta-blockers.

STRIVERDI RESPIMAT is for oral inhalation only.

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.

Indication

Striverdi® Respimat® (olodaterol) Inhalation Spray is a long-acting beta2-agonist indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Important Limitations: STRIVERDI RESPIMAT is not indicated to treat acute deteriorations of COPD and is not indicated to treat asthma.

Please see full Prescribing Information, including boxed WARNING, Medication Guide, and Instructions for Use. 

About COPD
Chronic obstructive pulmonary disease (COPD) includes chronic bronchitis and emphysema. This disease makes it harder to breathe because less air is able to flow in and out of the lungs. As many as 26 million Americans may have COPD even those who haven't smoked in years and nearly half of them remain undiagnosed. COPD is the third leading cause of death in the United States, killing one person every four minutes. Globally, the incidence of COPD is expected to increase in the coming decades.

Common symptoms of COPD include shortness of breath and coughing with or without excess mucus. COPD develops slowly, is progressive and irreversible, and symptoms often worsen over time, limiting people's ability to perform routine activities.

Leading Respiratory Forward
Through research, treatments and patient-centric support services, the Boehringer Ingelheim (BI) lung health portfolio is designed to help address the challenges people living with a lung disease face every day. 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 make a difference in the lives of patients with COPD, asthma, lung cancer, idiopathic pulmonary fibrosis and other respiratory diseases.

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.

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