Forest’s COPD drug approved in US
pharmafile | March 3, 2011 | News story | Sales and Marketing | COPD, Daliresp, Daxas, Forest, Forest Laboratories, chronic obstructive pulmonary disease, roflumilast
Daliresp (roflumilast) has been approved by the FDA to treat severe chronic obstructive pulmonary disease.
Forest Laboratories’ once-daily pill is the first and only selective phosphodiesterase-4 (PDE4) inhibitor to be approved in the US, where the company plans to launch it in the second quarter of 2011.
The approval is good news for Forest, following Daliresp’s initial rejection in April 2010 by an FDA committee which said evidence to support its filing was not substantial enough.
To date Daliresp’s efficacy and safety has now been evaluated in eight clinical studies involving 9,394 adult patients – 4,425 of which were treated with Daliresp.
Daliresp is already on the market in Europe, where it is co-promoted by Nycomed and Merck Sharpe & Dohme and known as Daxas, and Forest signed a deal with Nycomed in August 2009 to market the drug in the US.
Howard Solomon, chief executive and president of Forest Laboratories, said: “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.”
He added: “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.”
Brett Wells
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