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FDA OKs Forest Labs' Daliresp for COPD
March 2nd, 2011
NEW YORK – Forest Laboratories Inc. has obtained approval from the Food and Drug Administration for Daliresp (roflumilast) as a treatment for chronic obstructive pulmonary disease (COPD) exacerbations.
The company said Tuesday that Daliresp (roflumilast), an oral tablet taken once daily, specifically is indicated to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
According to Forest Labs, Daliresp is the first and only selective phosphodiesterase-4 (PDE4) inhibitor approved. The company said it expects Daliresp to be available to wholesalers in the second calendar quarter of 2011.
"We are pleased with the FDA approval of Daliresp, and we are looking forward to making this treatment available in the United States for the millions of patients suffering from severe COPD," stated Howard Solomon, chairman and chief executive officer of Forest Labs. "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."
COPD is an underdiagnosed, progressive, irreversible lung disease, Forest Labs reported. Symptoms of COPD include breathlessness, chronic cough and excessive production of phlegm. A significant worsening of symptoms, called an exacerbation, can last several weeks and often requires substantial medical intervention, including hospitalization.
"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," Professor Stephen Rennard, M.D., of the University of Nebraska Medical Center and a clinical trial investigator, said in a statement. "Reducing the risk of COPD exacerbations is an important goal of COPD treatment."