Novartis's megablockbuster COPD program faces key hurdle

Early next week Novartis will face a key hurdle in its quest to obtain an approval for a new COPD drug, indacaterol, as FDA experts line up to take a second look at the drug. And analysts say that the FDA's final word on the treatment will have a big impact on a megablockbuster showdown that's taking shape between Novartis and GlaxoSmithKline.

"This could be a $20 billion market and Novartis may set a new standard in COPD (chronic obstructive pulmonary disorder)," Helvea analyst Karl-Heinz Koch tells Reuters "There is still so much potential to improve what is out there. COPD is still not well treated."

The outcome of the panel vote will also have a big impact on GlaxoSmithKline (Advair) and Pfizer (Spiriva). Novartis wants both a 150 microgram and a 75 microgram dose of indacaterol approved. But analysts expect that the experts will zero in on safety risks associated with the drug, a long-acting beta agonist (LABA). And right now the FDA is being particularly vigilant related to drug safety.

Novartis is looking to build a clear lead over GSK, which recently launched a late-stage study of its own LAMA-LABA drug. Glaxo still faces a lengthy amount of work, though, while Novartis's once-daily QVA149 is well into its pivotal stage.

- here's the story from Reuters