EMA approves inhaled CF drug

A dry powder inhalation treatment for cystic fibrosis-related lung infections has been recommended for EU marketing approval by the European Medicines Association (EMA).

Colobreathe (colistimethate sodium) from Forest Laboratories UK is recommended for the treatment of chronic lung infection by Pseudomonas aeruginosa bacteria in cystic fibrosis (CF) patients aged six and older.

The recommendation follows a clinical study that showed Colobreathe to have better patient acceptance than, and be clinically non-inferior to, TOBI (inhaled tobramycin) from Novartis.

Forest plans to release Colobreathe across Europe from mid-2012, including the UK in September.

Colobreathe is delivered via the Turbospin inhaler, a relatively small (10cm long) portable device that uses the patient’s inhalation.

Crucially, data from the study submitted for authorisation of Colobreathe showed that overall the product was well tolerated and there was no emergence of resistance to the antibiotic.

Raymond Stafford, CEO of Forest Laboratories Europe, said: “Colobreathe is a real breakthrough which will aid patient compliance and lifestyle. The Turbospin inhaler is so small it can easily be carried, and administration is fast and uncomplicated.”

CF is a debilitating genetic disease that affects approximately 35,000 people in the EU, leading to life-threatening pulmonary infections.

Based in Dartford, Forest Laboratories UK develops and supplies prescription and OTC medications for a range of conditions.