- FDA granted approval for DalirespTM (roflumilast; marketed as Daxas® in the EU, Canada and other ex-US countries) in the United States as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD.
Nycomed’s US partner Forest Laboratories, Inc. (NYSE: FRX) announced today that DalirespTM (roflumilast) was approved by the US Food and Drug Administration (FDA) as a treatment to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
COPD is an under-diagnosed, progressive, irreversible lung disease. 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.
Daliresp is the first and only selective phosphodiesterase-4 (PDE4) inhibitor approved and is an oral tablet taken once daily. While the specific mechanism by which Daliresp exerts its therapeutic action in COPD patients is not well defined, it is thought to be related to the effects of increased intracellular cyclic AMP in lung cells. Forest expects Daliresp to be available to wholesalers in the second calendar quarter of 2011.
Commenting on today’s announcement, Guido Oelkers, Executive Vice President, Commercial Operations at Nycomed, said: “Nycomed is very pleased with the US approval of Daliresp by the FDA. With Forest we have an ideal partner, who is absolutely committed to make this innovative treatment available in the United States for the many patients suffering from severe COPD. The approval of Daliresp offers clinicians and patients a much needed new treatment option alongside existing inhaled therapies.”
“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,” said Professor Stephen Rennard, M.D., University of Nebraska Medical Center and clinical trial investigator. “Reducing the risk of COPD exacerbations is an important goal of COPD treatment.”
Roflumilast is an orally administered selective phosphodiesterase 4 (PDE4) enzyme inhibitor, which has been shown to inhibit COPD related inflammation with a novel mode of action1. Roflumilast, a once-a-day tablet, is the first drug in a new class of treatment for severe COPD and the first oral anti-inflammatory treatment specifically developed for COPD patients.
Four large randomized placebo controlled trials have shown that roflumilast significantly reduces exacerbations and improves lung function when added to first-line maintenance therapy.
Roflumilast is generally well tolerated. In clinical COPD trials involving 12,000 patients, the most commonly reported adverse reactions were diarrhoea (5.9%), weight decreased (3.4%), nausea (2.9%), abdominal pain (1.9%) and headache (1.7%). The majority of these adverse reactions were mild or moderate. These adverse reactions mainly occurred within the first weeks of therapy and mostly resolved on continued treatment.
Other pharmacological treatment for COPD patients includes the use of inhaled bronchodilators and inhaled corticosteroids.
Roflumilast has been approved in the European Union and Canada in 2010 and it is marketed under the brand name Daxas®. In February 2011 it received marketing authorisation from the Brazilian National Health Surveillance Agency (ANVISA). Daxas® has been launched in several countries already, as for example Germany, Denmark, Sweden, UK, Canada and Spain. It is scheduled to be launched in other markets in 2011.
In the US, roflumilast will be available in the second calendar quarter of 2011 and marketed exclusively by Forest Laboratories as DalirespTM. In August 2009 Forest Laboratories and Nycomed entered into a definitive collaboration and distribution agreement pursuant to which Forest acquired an exclusive license for Daliresp in the United States.
US Indication: DalirespTM is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of use: DalirespTM is not a bronchodilator and is not indicated for the relief of acute bronchospasm.
For further information on the US specific indication, safety and data highlights, please visit the Forest website: www.FRX.com
COPD remains a significant area of unmet medical need. It is a progressive and irreversible lung disease resulting in difficulty in breathing. The disease is characterised by severe episodes of worsening, called exacerbations or lung attacks. According to World Health Organization (WHO) estimates, 80 million people have moderate to severe COPD worldwide. More than 3 million people died of COPD in 2005, which corresponds to 5% of all deaths globally. 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. (www.who.int/respiratory/copd/burden/en/index.html)
Approximately 12 million people in the US are currently diagnosed with COPD and an additional 12 million are likely to have the disease and not know. Approximately half of COPD patients treated by a physician with controller medications have severe COPD. Of the patients diagnosed with severe COPD, almost three quarters, or 2.8 million, have chronic bronchitis.
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest's current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more about Forest Laboratories, visit www.FRX.com.
Nycomed is a privately owned global pharmaceutical company with a differentiated portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management. An extensive range of OTC products completes the portfolio.
Its R&D is structured around partnerships and in-licensing is a cornerstone of the company's growth strategy.
Nycomed employs 12,000 associates worldwide, and its products are available in more than 100 countries. It has strong platforms in Europe and in fast-growing markets such as Russia/CIS and Latin America. While the US and Japan are commercialised through best-in-class partners, Nycomed plans to further strengthen its own position in key Asian markets.
Headquartered in Zurich, Switzerland, the company generated total sales of €3.2 billion in 2009 and an adjusted EBITDA of €1.1 billion.
Hatzelmann A, Morcillo EJ, Lungarella G, et al. The preclinical pharmacology of roflumilast – a selective, oral phosphodiesterase 4 inhibitor in development for chronic obstructive pulmonary disease, Pulmonary Pharmacology & Therapeutics (2010), doi: 10.1016/j.pupt.2010.03.011