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‘Nycomed Submits For Regulatory Approval Of Daxas(R) In Europe’ A Novel Approach To The Management Of COPD

Posted May 17 2009 11:39pm

i1 The first in a new class of drugs that could challenge current thinking on the treatment of Chronic Obstructive Pulmonary Disease (COPD) has moved one step closer to market today. Nycomed announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for Daxas® (roflumilast) as a once-daily oral treatment for patients with COPD associated with chronic bronchitis.

Daxas is an orally-administered phosphodiesterase 4 (PDE4) enzyme inhibitor targeting cells and mediators in the body believed to be important in the COPD disease process. Daxas is expected to act on the underlying mechanism of COPD. It could significantly improve the way this condition is managed, including reducing exacerbations (episodes of worsening) requiring medical intervention. If approved, Daxas, a once-a-day tablet, will be the first drug in its class. Current treatment for COPD patients includes the use of inhaled bronchodilators and inhaled corticosteroids.

The MAA submission is based on encouraging results from four Phase III trials of Daxas in the treatment of symptomatic COPD. Two pivotal 12-month studies met their primary endpoints, showing beneficial effects on exacerbation rates and pulmonary function (FEV1). Two supporting 6-month studies also confirmed the efficacy of Daxas when used with standard bronchodilator treatments. Full data from all four studies are to be published during 2009.

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