Boehringer Ingelheim recently announced regulatory authority approvals in the first European countries for its Spiolto Respimat (tiotropium/olodaterol) therapy. The drug is a maintenance bronchodilator treatment designed to ease symptoms in adult patients suffering from chronic obstructive pulmonary disease (COPD). Boehringer did not stipulate in its press release which European countries are included in the first round of approvals.
In the coming months the company expects the drug to be approved in other European countries as well. Spiolto Respimat has been found to improve breathlessness, quality of life, and lung function, as well as serve as a rescue medication when patients require maintenance therapy. These benefits could allow patients to remain active and avoid the progressive nature of COPD symptoms.
COPD is a chronic, progressive, treatable but incurable lung disease predominantly caused by smoking and is characterized by airflow obstruction that is not fully reversible. The airflow obstruction does not change markedly over several months but is usually progressive in the long term. Exacerbations often occur, when there is a rapid and sustained worsening of the patient’s symptoms beyond normal day-to-day variations. The disease affects 210 million people worldwide and is predicted to become the 3rd leading cause of death by 2030. There is no single diagnostic test for COPD. Diagnosis relies on a combination of history, physical examination and confirmation of airflow obstruction using spirometry
“The additional benefits gained from Spiolto Respimat compared to Spiriva are significant for patients and data show the lung function benefits are even greater when used in the initial stages of COPD. It is a promising new therapeutic advance in COPD,” said Roland Buhl, professor of medicine and head of the pulmonary department at Mainz University Hospital in a recent news release.“Optimal management right from the start of maintenance therapy may give patients with this highly debilitating lung disease, the best opportunity to stay active, manage their symptoms and have a better quality of life.”, he added.
The approval was based on the results of the TONADO 1&2 clinical studies which involved >15,000 patients. Results from the TOviTO clinical trial, part of the TONADO study, showed that Spiolto Respimat provided clinically relevant improvements over Spiriva.
In terms of lung function improvement, results from the trial program showed that the best results were observed in the group of COPD patients during the first stage of needing maintenance therapy – and the lung function improvement more than doubled in COPD patients who had no prior maintenance therapy (148ml vs. 72ml).
The drug was found to reduce breathlessness and also reduce the use of rescue medication among COPD patients (22% and 26% improvement in use of night-time and daytime and rescue medication in comparison with Spiriva). In terms of quality of life, the results showed that more patients experienced improvements (57.5% versus 48.7%). Results from the safety analysis showed that Spiolto Respimat was well tolerated and similar to olodaterol or tiotropium alone.
“Since its first launch in 2002, Spiriva has brought medical benefits that have made a real difference to the lives of millions of patients with COPD around the world. Spiolto Respimat is our newest advance in COPD treatment. Its recent approval in the US, Canada and Australia, alongside the approval in countries across Europe, is an important step forward in our ongoing commitment to provide effective solutions for patients with COPD,” said Klaus Dugi, chief medical officer at Boehringer Ingelheim. “We anticipate further approvals of Spiolto Respimat in other European countries over the coming months.”
Stiolto is administered via Respimat, the propellant-free, platform inhaler for Boehringer Ingelheim’s respiratory therapies, including approved and investigational therapies. Respimat is the only inhaler available that actively delivers a unique mist, meaning the patient just needs to breathe in naturally for the medication to go deep into the lungs. The drug is developed based on tiotropium, the active constituent in Spiriva — the most prescribed maintenance treatment for COPD. It is enriched by olodaterol, an effective long-acting beta2-agonist with a fast mechanism of action, designed to supplement the efficacy of Spiriva.