FDA experts turn thumbs down on Novartis's high-dose COPD drug

An FDA advisory committee has given Novartis ($NVS) a key endorsement for a low-dose version of its inhaled COPD treatment indacaterol. But analysts fretted over the blockbuster implications of the experts' decision to withhold the green flag from a high dose needed for a closely-watched combo therapy now in development.

The advisory panel came down solidly in favor of the 75 microgram dose of indacaterol, voting 13 to 4 to recommend a formal approval by the agency. But this is just one step in Novartis's long journey to a combo treatment that is intended to match a 150 microgram dose of indacaterol--a long-acting beta agonist--with a long-acting muscarinic antagonist. That experimental treatment, dubbed QVA149, could go on to achieve peak annual sales of $5 billion a year.

"They may have to go back and reformulate the combination," Miller Tabak portfolio manager Les Funtleyder told Reuters. "But Novartis has a lot on its plate. It's good to be a big diverse company."

Researchers failed to make a compelling case for the 150 microgram dose, leaving a majority of the panel to conclude that there was no clear added benefit to be had from the high dose of the drug, which raises the risks of an adverse event.

- read the Novartis release
- check out the story from Reuters
- and here's the Dow Jones report

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