Boehringer Ingelheim has announced regulatory authority approvals for Spiolto Respimat ( Tiotropium / Olodaterol ) in first European countries [ As of 29th June, Spiolto Respimat has been approved in Croatia, United Kingdom, Slovakia, Denmark, Norway, Ireland, Austria, Romania and Spain ].
Spiolto Respimat is a once-daily maintenance treatment to relieve 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.
Spiolto Respimat provides significant improvements in lung function, breathlessness, quality of life and rescue medication use over Spiriva right from the initial stages when patients need maintenance therapy. These additional benefits could enable patients to remain active and avoid the downward spiral of COPD for as long as possible.
COPD is a chronic, progressive, treatable but incurable lung disease that affects 210 million people worldwide and is predicted to become the 3rd leading cause of death by 2030.
Patients are typically diagnosed when lung function is already significantly impaired and maintenance therapy is needed. They suffer from symptoms including breathlessness and coughing that often stop them from being active. This can lead to a downward spiral of worsening symptoms and even further inactivity, contributing to an increased risk of disability and death.
The national regulatory approvals, following finalisation of the decentralised European regulatory procedure on 20th May, are based on data from the more than 5,000 patient TONADO 1&2 clinical trials.
The TONADO trials are part of the more than15,000 patient TOviTO clinical trial programme which shows Spiolto Respimat provides clinically relevant improvements over Spiriva:
a) significant improvement in lung function, with greatest benefit seen in patients who are at the first stage of needing maintenance therapy for their COPD – and more than double the improvement in lung function in patients who had no prior maintenance therapy ( 148 vs 72 ml);
b) reduction in breathlessness and less use of rescue medication among patients ( 22% and 26% improvement in use of daytime and night-time rescue medication over Spiriva respectively );
c) 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.
Spiolto Respimat is built on Tiotropium, the active ingredient in Spiriva - the world’s most prescribed COPD maintenance treatment with over 40 million patient years of real life experience across all COPD severities.
It is enhanced by Olodaterol, a unique and effective long-acting beta2-agonist with a fast onset of action, specifically designed to complement the efficacy of Spiriva.
Spiolto is delivered by Respimat, 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. ( Xagena )
Source: Boehringer Ingelheim, 2015