EU submission for GSK and Theravance COPD drug
pharmafile | January 11, 2013 | News story | Sales and Marketing | COPD, GSK, Theravance, UMEC/VI
GlaxoSmithKline and Theravance have submitted their chronic obstructive pulmonary disease (COPD) drug UMEC/VI to European regulators.
The application follows the investigational once-daily long-acting muscarinic antagonist (LAMA) and long-acting beta agonist (LABA), combination medicine being put before the FDA in December.
GSK hopes this will become a next-generation treatment to succeed its $5 billion lung drug Advair/Seretide. Rivals include Merck’s once-daily pill Daxas (roflumilast).
The new drug combines two investigational bronchodilator molecules – LAMA GSK573719 or umeclidinium bromide (UMEC) and LABA vilanterol (VI) – which patients will take using the Ellipta inhaler.
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.
If approved UMEC/VI will be marketed under the brand name Anoro, and the companies say more regulatory submissions in other countries are planned this year. GSK says it also wants to submit UMEC as monotherapy later in 2013.
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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