Forest, Nycomed win narrow FDA approval on new COPD drug

Forest Labs and Switzerland's Nycomed have managed to overcome some sharp criticism from a panel of experts and win a narrow approval of Daliresp (roflumilast) to prevent the exacerbation of COPD.

Last spring the FDA panel voted thumbs down on the drug---called Daxas in the European market--in a 10 to 5 vote against approval. The experts determined that the drug was safe but worried that the therapy's meager impact on the lungs didn't justify running the risk of potential side effects. But after demanding and getting more info from the developers, regulators appeared to be won over by the drug's ability to prevent breathlessness, chronic cough and excessive production of phlegm.

Nycomed scooped up a $100 million upfront from Forest when they inked a licensing pact in 2009. And it was lined up for another $500 million in milestones on a drug analysts once believed could earn about half a billion dollars a year. Those earnings estimates, though, are likely to be significantly reduced. The developers had initially sought an approval to use the drug for the broad treatment of COPD. It ended up with a narrower approval for preventing exacerbations. 

"The introduction of Daliresp as an additional treatment option to reduce the risk of COPD exacerbations is an important development for patients with severe COPD associated with chronic bronchitis and a history of exacerbations," said Professor Stephen Rennard, M.D., University of Nebraska Medical Center and clinical trial investigator. "Reducing the risk of COPD exacerbations is an important goal of COPD treatment."

- get the Nycomed release
- read Bloomberg's report
- and here's the story from Reuters