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, March 23, 2012.
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.
Advair is now off patent in the USA and Europe, but has faced little generic competition so far because of difficulties in copying the inhaled product.
If all goes well, industry analysts believe Relovair should reach the market in 2013. However, cases of fatal pneumonia linked to Relovair revealed in the studies could mean that the drug will not gain regulatory approval in the USA, according to a Deutsche Bank analyst quoted by the Financial Times earlier this year.
The full results of all these studies will be presented at future scientific meetings.