GSK Plans Filing For Respiratory Triple Combo Drug
GlaxoSmithKlin and the biopharmaceutical company, Innoviva, plan to to file a new drug application (NDA) in the US for the once-daily closed triple combination therapy, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), a combination inhaled corticosteroid, long-acting muscarinic antagonist, long-acting beta agonist for patients with chronic obstructive pulmonary disease (COPD). The US regulatory submission is now anticipated by the end of 2016, rather than the first half of 2018, as previously expected.
The NDA for the closed triple combination therapy will comprise data now in hand from the closed triple combination therapy development programme, as well as data from studies with FF, UMEC and VI either alone or in combination.
The companies continue to expect an regulatory submission in the European Union of the closed triple combination therapy for COPD by the end of 2016.
he closed triple therapy is a combination of three molecules: fluticasone furoate, an inhaled corticosteroid; umeclidinium, an anti-cholinergic, also known as a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist delivered once-daily in GSK's Ellipta dry-powder inhaler.