Novartis wins FDA OK of low-dose COPD therapy

Two years after the FDA originally stiff-armed Novartis on indacaterol inhalation powder regulators finally gave the COPD treatment a green light at a low dose. Word of the approval spread late on Friday afternoon that regulators had finally signed off on the 75 mcg dose of Arcapta Neohaler, which is now in widespread use around the globe.

Novartis, which has been garnering a string of regulatory wins in recent months, had hoped to get the stronger 150 mcg dose approved to help set up its closely watched study of a new COPD treatment that combines a LABA and LAMA treatment. But Novartis insists it can adapt quickly to the lower dose as it races against time and GlaxoSmithKline. This new COPD treatment should prove only a modest revenue generator for Novartis, while a combined product is expected to swiftly achieve blockbuster status.

"With millions of Americans known to be affected by COPD, the approval of Arcapta is good news for patients," said John W. Walsh, president and co-founder of the US-based COPD Foundation. "A new once-daily medicine is a welcome addition to the treatment options for people suffering with this serious and debilitating disease."

- see the Novartis release
- here's the story from Reuters