A new treatment for COPD has been approved for use in a number of European countries.
Spiolto Respimat (tiotropium olodaterol) has been approved for use in Croatia, United Kingdom, Slovakia, Denmark, Norway, Ireland, Austria, Romania and Spain.
The once-daily maintenance treatment relieves symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Approvals of the treatment in other European countries are expected to follow in the coming months. It has been proven to provide significant improvements in lung function, COPD symptoms, quality of life and rescue medication use over Spiriva. It has also been proven to more than doubles lung function improvement over Spiriva in patients who had no prior maintenance therapy.
COPD affects 210 million people worldwide and is predicted to become the 3rd leading cause of death by 2030. The condition is incurable but can be managed with effective treatment.
Roland Buhl, Professor of Medicine and Head of the Pulmonary Department at Mainz University Hospital, said: “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.
“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.”
The national regulatory approvals, following finalisation of the decentralised European regulatory procedure on 20th May, are based on data from the >5,000 patient TONADO 1&2 clinical trials. The TONADO trials are part of the >15,000 patient TOviTO clinical trial programme which shows Spiolto Respimat provides clinically relevant improvements over Spiriva:
- Significant improvement in lung function, with greatest benefit seen in patients who are at the first stage of needing maintenance therapy for their COPD8 – and more than double the improvement in lung function in patients who had no prior maintenance therapy§ (148ml vs. 72ml)
- Reduction in breathlessness and less use of rescue medication among patients1 (22% and 26% improvement in use of daytime and night-time rescue medication over Spiriva respectively)
- More patients experiencing noticeable improvements in their quality of life (57.5% vs 48.7%)
- Spiolto Respimat was well tolerated with a safety profile that was similar to tiotropium or olodaterol alone.