GSK submits UMEC monotherapy
pharmafile | April 29, 2013 | News story | Sales and Marketing |Â Â COPD, EMA, GSK, UMECÂ
GlaxoSmithKline has put its investigational once-daily medicine umeclidinium bromide (UMEC) up for scrutiny by European regulators for patients with chronic obstructive pulmonary disease (COPD).
The investigational bronchodilator molecule is a long-acting muscarinic antagonist (LAMA), administered using the Ellipta inhaler, and the application is for UMEC monotherapy (55 mcg) as a maintenance bronchodilator treatment to relieve COPD symptoms in adults.
GSK promises more filings for this monotherapy in various countries during 2013, and says one is ‘imminent’ in the US.
Earlier this year, GSK and Theravance submitted a combination of UMEC and long-acting beta agonist (LABA) VI to the EMA, following a similar filing with the FDA in December.
GSK has high hopes for the combination – which would be given the brand name Anoro if successful – with the ultimate goal of its becoming a next-generation treatment to succeed $5 billion lung drug Advair/Seretide.
Patients would again take this with the Ellipta inhaler, and rivals would include Merck’s once-daily pill Daxas (roflumilast).
Results from four late-stage trials suggest UMEC/VI helps patients breathe more easily, with Phase III data showing statistically significant improvements when compared with its individual components alone and to placebo.
UMEC/VI also fared well in trials against Boehringer/Pfizer’s established drug Spiriva (tiotropium). The EU submission sees UMEC/VI (55/22mcg and 113/22mcg delivered doses) used as maintenance treatment to relieve COPD symptoms in adults.
The amounts are the same as the 62.5/25mcg and 125/25mcg pre-dispensed doses, which are contained inside the inhaler, in the US submission.
The manufacturer’s respiratory pipeline looks strong at present, with fluticasone furoate/vilanterol (FF/VI), whose proposed brand names are Relvar and Breo, also in development.
Other investigational medicines include VI monotherapy, MABA (GSK961081), developed in collaboration with Theravance, as well as FF monotherapy and anti-IL5 MAb (mepolizumab).
The World Health Organisation estimates that more than 21 million people are currently living with COPD.
Adam Hill
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