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

Main Category: COPD
Also Included In: Respiratory / Asthma;  Regulatory Affairs / Drug Approvals
Article Date: 14 May 2009 - 5:00 PDT

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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.

Commenting on today's announcement, Håkan Björklund, Chief Executive Officer of Nycomed, said: "With its novel mode of action, Daxas represents an important new approach in the management of COPD - a disease which is predicted to become the third leading cause of death worldwide by 2030. Today's submission for Daxas, subject to acceptance and approval by the EMEA, represents a significant milestone for Nycomed."

Peter Calverley, Professor of Medicine in the Pulmonary and Rehabilitation Research Group at the University of Liverpool, and lead investigator in the roflumilast clinical programme commented: "This EU filing for roflumilast is an important milestone in our response to the major health problems associated with the increasing COPD burden. The prospect of targeting the inflammatory processes in COPD is good news for doctors and patients. This will provide us with a new approach to tackle this disease that targets the underlying mechanism. For patients, this development brings the possibility of reducing the number of serious exacerbations they experience, one of their major fears."

COPD remains a significant area of unmet medical need. It is a progressive and irreversible lung disease resulting in difficulty in breathing. According to the World Health Organization (WHO) estimates, 80 million people have moderate to severe COPD worldwide.1 More than three million people died of COPD in 2005, which corresponds to 5% of all deaths globally.1 The WHO predicts that total deaths from COPD could increase by more than 30% in the next 10 years unless urgent action is taken to reduce the underlying risk factors, especially smoking.1

According to the British Thoracic Society, recent figures show more than 27,000 people die of COPD each year in the UK.2 The underlying prevalence of COPD is now estimated to be more than 4 million.3 It is estimated that COPD causes at least 20.4 million lost working days amongst men and 3.5 million among women every year, more than any other respiratory condition.4

References:

1. World Health Organization. Available here.[last accessed 7 May 2009].

2. British Thoracic Society. The burden of lung disease 2006. Available here. [last accessed 7 May 2009].

3. Hill SL et al. Introducing a National Strategy for COPD in England. Am J Respir Crit Care 2009; 179: A2897.

4. British Lung Foundation briefing. COPD - September 2006. Available here. [last accessed 7 May 2009].

About Daxas

Nycomed is also preparing for the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Daxas as a once-daily oral treatment for patients with COPD associated with chronic bronchitis.

Source
Nycomed