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Chiesi Group's Trimbow wins European licence

European Commission approves the COPD treatment


The European Commission has approved Chiesi Group’s Trimbow to treat adults with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.

The treatment comprises an inhaled corticosteroid (ICS), long-acting beta2-agonist (LABA) and long-acting muscarinic antagonist (LAMA) in one inhaler and is the such triple combination COPD therapy to be approved in Europe.

Alessandro Chiesi, region Europe Head of Chiesi Group, said: “The marketing authorisation of Trimbow in the EU is a significant treatment advance for COPD patients and reinforces the Chiesi Group’s leadership in the respiratory arena.”

Administered twice daily at a fixed dose, Trimbow was found superior to standard treatment - a combination of ICS/LABA and LAMA in two separate inhalers - thanks to two 12-month TRILOGY and TRINITY studies.

However, more than 70% of COPD patients do not follow the therapy correctly, and this is often due to multiple inhalers according to Chiesi, who added: “The use of one inhaler should simplify the intake of the therapy and therefore may improve adherence.”

Additionally, the studies also proved that the medicine is able to reduce the yearly exacerbation rate more than 20%, significantly decrease dyspnoea and improve the lung function while maintaining a “good safety profile”.

Dave Singh, professor of Clinical Pharmacology and Respiratory Medicine at Manchester University, said: “This is the first time that we have seen an effect of triple therapy on exacerbations.

“These studies show a consistent effect of the extrafine fixed triple therapy combination on a range of outcomes including lung function and quality of life.”

Although the first medicine of its type approved in the EU, Trimbow could face competition next year from GlaxoSmithKline’s triple combination therapy, which was filed for EU approval back in December.

Article by
Gemma Jones

2nd August 2017

From: Regulatory



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