LONDON GlaxoSmithKline reiterated a plan to submit its key new lung drug Relovair for regulatory approval in mid-2012, despite releasing another batch of mixed clinical trial results on Friday.
The new once-a-day inhaled medicine showed superiority to GSK's existing twice-daily drug Advair in one trial for chronic lung disease, but not another. That patchy record echoes results of other studies in an extensive development program.
Britain's biggest drugmaker, however, remains confident in the product. It hopes the convenience of once-daily dosing will appeal to patients, helping it carve out a position as a replacement for Advair, which has annual worldwide revenue of more than $8 billion and is GSK's biggest seller.
GSK said Relovair, which is being developed with Theravance, would be filed for chronic obstructive pulmonary disease (COPD) in the United States and Europe in the middle of the year.
It will also be submitted as a new treatment for asthma in Europe at the same time. In the United States GSK will continue discussions with regulators on its use in asthma.