Forest COPD drug wins US approval

Forest Laboratories has won approval from the US Food and Drug Administration (FDA) for its chronic obstructive pulmonary disease (COPD) drug Daliresp (roflumilast).

The once-daily pill is intended to decrease the frequency of flare-ups or worsening of symptoms in adult patients with severe COPD. Forest expects to launch the product to wholesalers in the second calendar quarter of 2011.

"The approval of Daliresp gives physicians and patients a much needed treatment option in a unique oral dosage form that can augment the existing armamentarium of inhaled therapies," according to the company.

Forest licensed the drug from Nycomed in a 2009 deal and took over the marketing application, making the requested indication more restrictive and adding a warning about neuropsychiatric adverse effects.

In April 2010, the FDA's Pulmonary-Allergy Drugs Advisory Committee voted 10 to five against recommending approval of the phosphodiesterase 4 inhibitor, concluding that the potential for adverse events was not adequately offset by the drug's relatively modest efficacy.

The FDA will require that Daliresp be marketed with a medication guide informing patients of the potential risks of mental health problems, including changes in mood, thinking, or behaviour. The medication guide will warn that patients, their caregivers, and families should be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts or other mood changes.

In addition, the guide will warn of the risk of unexplained weight loss and will state that patients treated with Daliresp should have their weight monitored regularly and should possibly discontinue the drug if significant weight loss occurs.

Roflumilast was approved for marketing in Europe under the brandname Daxas in July 2010.