Lung Disease Drug Trials Point Toward ApprovalBy: Sean Patterson - August 27, 2012
GlaxoSmithKline (GSK) this week announced that phase III of trials for its new long-acting muscarinic antagonist/long-acting beta2 agonist (LAMA/LABA) drug are complete. The drug, which is administered via inhaler, is a once-daily medicine for treatment of chronic obstructive pulmonary disease (COPD), one of the most common forms of lung disease. The trials involved around 6,000 patients with COPD. The medication was developed in association with Theravance, a biopharmaceutical research company.
According to GSK, the LAMA/LABA being studied is a combination of two molecules – umeclidinium bromide (UMEC) and vilanterol. The UMEC is the experimental aspect of the medication that is currently being developed for the treatment of COPD. A 50-week safety study of UMEC and vilanterol has been completed, as well as two different 12-week crossover exercise studies.
The trials appear to be a success, though the results of this study and others will be presented “at future scientific meetings.” Still, GSK stated that it intends to file for approval of the drug throughout its global markets.
The UMEC and vilanterol LAMA/LABA is only one of a few respiratory drugs GSK is researching. It already has tradmarks on the brand names RELVAR and BREO for a fluticasone furoate/vilanterol drug, though it too is not yet approved anywhere. These drugs have the potential to become GSK’s next generation of respiratory treatment drugs. GSK currently markets Advair as a treatment for respiratory symptoms.