New Spiriva® Respimat® inhaler completes European approval process for COPD

Boehringer IngelheimBoehringer Ingelheim and Pfizer today announced successful completion of the approval process for authorisation to market Spiriva® Respimat® in the European Union for people with chronic obstructive pulmonary disease (COPD). This positive opinion for the Spiriva® Respimat® is the cornerstone of all national approvals in 25 countries of the European Union. Spiriva® Respimat® is a propellant-free, new generation inhaler that combines innovative technology with the proven efficacy of Spiriva® (tiotropium).

"Spiriva® Respimat® represents a major step forward in COPD and inhalation therapy. Many patients find certain inhaler devices difficult to coordinate and use," said Professor Marc Decramer, Respiratory Division, University Hospitals, Katholieke Universiteit Leuven, Belgium "Spiriva® Respimat® has a unique and sophisticated delivery system, and a user friendly design, making it easy to use and suitable for a broad range of patients with COPD. In addition the long-lasting, soft mist cloud generated by Spiriva® Respimat® ensures optimised delivery of Spiriva® to the lungs, helping patients breathe more easily," he added.

In clinical studies comparing inhaler devices, patients preferred Respimat® Soft Mist™ Inhaler, which may help increase patient compliance with therapy. The novel dose-delivery system of the Spiriva® Respimat® also means that unlike dry powder inhalers, the dose delivered is not dependent on patients' inspiratory flow.

Spiriva® (tiotropium), a first-line maintenance therapy for COPD, positively impacts the clinical course of the disease, helping to change the way patients live with their condition. The efficacy of Spiriva® has been demonstrated by an extensive clinical development programme, which has treated over 25,000 patients.1 It is the most prescribed brand in COPD in the world.

The Spiriva® Respimat® delivery system relies on energy released from a spring, rather than propellants, to produce a long-lasting, slow moving Soft Mist™. The innovative design makes Spiriva® Respimat® easy to use, and the Soft Mist™ results in improved delivery of Spiriva® to the lungs, with reduced deposition in the mouth and throat compared to a pressurised metered dose inhaler (pMDI). One study showed that 72% of all patients use pMDIs incorrectly and almost half (47%) have problems with coordinating use of the device.

600 million people worldwide live with COPD and its prevalence is predicted to rise making it the world's third leading cause of death by 2020.10,11 It is estimated that up to 50% of Americans and 75% of Europeans with COPD are undiagnosed.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates in 47 countries and 38,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2006, Boehringer Ingelheim posted net sales of 10.6 billion Euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development. For further information, please visit www.boehringer-ingelheim.com.

About Pfizer Inc
Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals, and many of the world's best-known consumer products. For further information, please visit www.pfizer.com.

Most Popular Now

Study finds lack of racial diversity in cancer dru…

New research published in JAMA Oncology has found a lack of racial and ethnic diversity in clinical trials for cancer drugs. The study - conducted by researchers from UBC...

Preventing tumor metastasis

Researchers at the Paul Scherrer Institute, together with colleagues from the pharmaceutical company F. Hoffmann-La Roche AG, have taken an important step towards the dev...

A new drug could revolutionize the treatment of ne…

The international team of scientists from Gero Discovery LLC, the Institute of Biomedical Research of Salamanca, and Nanosyn, Inc. has found a potential drug that may pre...

Interactions discovered in cells insulating nerve …

Schwann cells form a protective sheath around nerve fibres and ensure that nerve impulses are transmitted rapidly. If these cells are missing or damaged, severe neurologi...

Roche's first FDA-approved tumour-agnostic medicin…

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Rozlytrek™ (entrectinib) for the treatment of adults with R...

Anniversary of the pivotal RE-LY® trial marks a de…

Boehringer Ingelheim today announces the ten-year anniversary of the RE-LY® trial publication(1-3) recognising the contribution made in the decade since by patients, heal...

AstraZeneca agrees to buy US FDA Priority Review V…

AstraZeneca announced that it has agreed to buy a US Food and Drug Administration (FDA) Priority Review Voucher (PRV) for a total cash consideration of $95m from a subsid...

The Pfizer Foundation invests in 20 organizations …

The Pfizer Foundation announced 20 grants* to help non-governmental organizations (NGOs), non-profits and social enterprises address critical health challenges related to...

FDA grants Fast Track designation for Farxiga in c…

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to delay the ...

Pfizer invests half billion dollars to advance sta…

Pfizer announced an additional half billion dollar investment for the construction of its state-of-the-art gene therapy manufacturing facility in Sanford, North Carolina...

Amgen and Allergan announce positive top-line resu…

Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced positive top-line results from a comparative clinical study evaluating the efficacy and safety of ABP 798...

Breast cancer can form 'sleeper cells' after drug …

Breast cancer medicines may force some cancer cells into 'sleeper mode', allowing them to potentially come back to life years after initial treatment. These are the early...