Published July 02, 2012
GlaxoSmithKline's experimental once-daily lung drug LAMA/LABA showed positive results on Monday from late stage trials in patients with chronic obstructive pulmonary disease (COPD).
The Phase III data for the drug, which GSK is developing with Theravance, will support the British drugmaker's plans to start global filings to regulators for the combination pill from the end of this year, the drugmaker said in a statement.
GSK is working hard to develop next-generation medicines to become successors to its $8 billion lung drug Advair.
But its hopes are not only resting on the novel LAMA/LABA combination drug. GSK also has high hopes for its "son of Advair" drug, Relovair, also being developed with Theravance, which combines a LABA and an inhaled corticosteroid (ICS).
LAMA/LABA is a combination of two molecules - umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered by a new dry powder inhaler.
The new Phase III data showed the combination drug produced statistically significant improvements when compared with its individual components alone, and compared to placebo, in two 24-week trial involving around 1,500 patients each.
Two further studies compared LAMA/LABA against Spiriva, known generically as tiotropium, and also found statistically significant positive results for the GSK combination pill.
GSK said the most common adverse events across all four studies in all treatment arms, including placebo, were headaches, common colds, upper respiratory tract infections, cough, sore throats and back pain.
Darrell Baker of GSK's respiratory portfolio division said LAMA/LABA was an important cornerstone of the firm's broad respiratory portfolio.
"Subject to successful completion of the ongoing studies, we plan to commence global regulatory filings from the end of this year," he said in a statement.