Statement From President John W. Walsh on FDA Pulmonary-Allergy Drugs Advisory Committee Meeting

March 24, 2011

On behalf of the COPD Foundation, a not-for-profit organization representing the millions of Americans affected by COPD, I am pleased to present comments and express our appreciation for your consideration of this NDA for indacaterol maleate—a once-a-day maintenance treatment for COPD.

This past December, the CDC announced that COPD is now been elevated to the third leading cause of death in the United States. There are 12 million Americans currently diagnosed with COPD but the National Heart, Lung and Blood Institute estimates that another 12 million are affected but undiagnosed. COPD costs the U.S. healthcare system over $50 billion annually. In addition, COPD is the only major chronic disease increasing in mortality. A person dies of COPD every 4 minutes!

We applaud the FDA for its efforts in accelerating the approval of new therapies for COPD. However, we would all agree that it is unacceptable that the COPD Community only has a handful of approved therapies available for such a large number of affected individuals.  As someone diagnosed with Alpha-1-related genetic COPD since 1989, I understand the patient’s needs.  With our physicians’ guidance, we want to have choice and access to the best possible combination of therapies.

Treatment guidelines recommend that individuals with moderate or more severe COPD begin treatment with one or more long-acting bronchodilators for their maintenance therapy. Currently available LABAs are administered twice daily or nebulized. As we all know, adherence is a great challenge for people dealing with several chronic conditions so we have to make it as simple as possible. Reducing the number of times and simplifying the process of taking medications would improve adherence among members of our community.

The advantages of having a once-a-day LABA available to increase compliance and improve adherence cannot be overstated. In addition, having a choice on what LABA to use or the ability to combine therapies, gives our physicians the option to adjust our treatment regimen to better fit our needs and improve outcomes. For example, the possibility of combining a once-a-day LABA with a once-a-day LAMA (like tiotropium) may help a countless number of individuals living with advanced COPD and could reduce the need to use medications such as inhaled corticosteroids.

We are also concerned about the confusion over the validity of using symptomatic benefit for drug approval. From a patient’s perspective, without alleviating the shortness of breath, wheezing, chronic coughing and frequent exacerbations, among other symptoms, you cannot improve the quality of life for the affected individual.  A better quality of life means exactly that.

Once again, I would like to express our appreciation to you for your focus on COPD and for your continued dedication to accelerating the approval of new safe and efficacious drugs.

-- John W. Walsh