FDA accepts GSK’s Anoro
pharmafile | February 20, 2013 | News story | Research and Development, Sales and Marketing | FDA, GSK, Theravance, anoro
The FDA has accepted a New Drug Application for GlaxoSmithKline and biopharma firm Theravance’s investigational COPD drug UMEC/VI.
A decision by the US regulator on the once-daily LAMA/LABA combination medicine – whose proposed brand name is Anoro and would be administered using the Ellipta inhaler – is expected on or before 18 December.
The drug brings together two investigational bronchodilator molecules: GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta agonist (LABA).
UMEC/VI was filed with the FDA last December and with European regulators last month.
The manufacturers says regulatory submissions are planned in other countries this year, and GSK intends to do the same for UMEC monotherapy in COPD patients later this year.
GSK hopes Anoro, if approved, will be a next-generation treatment to succeed its $5 billion lung drug Advair/Seretide. Rivals include Merck’s once-daily pill Daxas (roflumilast).
Results from four late-stage trials suggest UMEC/VI helps patients breathe more easily and it also did well against Boehringer/Pfizer’s established drug Spiriva (tiotropium).
Phase III data suggests statistically significant improvements when UMEC/VI is compared with its individual components alone and to placebo.
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.
GSK’s respiratory portfolio looks strong at present. As well as VI monotherapy, other drugs – none of which are approved anywhere – include fluticasone furoate/vilanterol (FF/VI), whose proposed brand names are Relvar and Breo, co-developed with Theravance.
There is also MABA (GSK961081), with Theravance again, and GSK’s investigational medicines FF monotherapy, UMEC 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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