Forest Laboratories UK applies for marketing authorisation for dry powder inhalation antibiotic
Forest Laboratories UK (a subsidiary of global pharmaceutical company Forest Laboratories Inc) has applied to the European Medicines Evaluation Agency (EMEA) to license its new formulation dry powder colistimethate sodium for inhalation by cystic fibrosis patients.
Forest Laboratories UK (a subsidiary of global pharmaceutical company Forest Laboratories Inc) has applied to the European Medicines Evaluation Agency (EMEA) to license its new formulation dry powder colistimethate sodium for inhalation by cystic fibrosis patients.
The new formulation, called Colobreathe, has previously been granted orphan drug status by EMEA and when approved will be made available throughout the EU by Gruenenthal of Germany.
The application follows the successful completion of a pan-European multi-centre phase III study.
Colobreathe belongs to the group of antibiotics known as polymixins. It works by disrupting the structure of the bacterial cell membrane causing the vital contents to leak out. Ultimately this process kills the bacteria.
Raymond Stafford, chief executive of Forest Laboratories Europe, said: "We believe that we have created a real advance in the management of infection in cystic fibrosis and are grateful for the support, encouragement and co-operation that the cystic fibrosis centres across Europe have given us. The reaction from patients has been very encouraging, and this treatment really can make a difference to their day to day quality of life."
