Chiesi Group said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended that the EMA approve its extra-fine triple combination inhaler for the treatment of chronic obstructive pulmonary disease.
The Trimbow device combines an inhaled corticosteroid, a long-acting beta2-agonist and a long-acting muscarinic antagonist. The healthcare group said it is the 1st time the extra-fine triple therapy has been available in a single inhaler.
“Today’s positive opinion is an important step forward to make our extrafine Triple combination available to COPD patients,” VP and head of R&D, Paolo Chiesi, said in prepared remarks. “COPD affects millions of people across Europe, and Chiesi is committed to developing new therapeutic options that could help these patients’ adherence to the therapy, thus reducing the risk of exacerbations and improving their quality of life. With this goal in mind, Chiesi has also developed the 1st fixed dose ICS/LABA/LAMA triple combination.”
Patients with COPD often have to take several drugs that can require 2 or even 3 inhalers, the company said, adding that a single inhaler that can deliver 3 different drugs could improve adherence.
The committee’s recommendation was supported by efficacy and safety data from 12 clinical studies. Recent trials have shown that the triple combination therapy performs better than standard treatments based on efficacy parameters such as exacerbations.
The company said it expects a final marketing authorization decision from the European Commission during the 3rd quarter of 2017.