GlaxoSmithKline has completed final stage testing of its experimental once-daily lung disease drug LAMA/LABA and will press ahead with plans to file for approval of the medicine in global markets from the end of the year.
In a statement yesterday, the British drug maker said a 52-week safety study, the last in a programme of trials which also included four pivotal studies of the drug, was now complete.
GSK, which is developing the LAMA/LABA combination medicine with Theravance, said last month that it had showed positive results in four late-stage trials in patients with chronic obstructive pulmonary disease.
“The full results of all these studies ... will be presented at future scientific meetings,” the firm said.
LAMA/LABA is a combination of two molecules – umeclidinium bromide, a long-acting muscarinic antagonist and vilanterol, a long-acting beta2 agonist, administered by a new dry powder inhaler.
GSK is working hard to develop next-generationmedicines to become successors to its $8 billion lung drug Advair.
Advair and Pfizer’s Spiriva currently dominate the res-piratory drug market but Swiss firm Novartis is also fighting the next generation battle with its experimental combination drug QVA149.