The U.S. Food and Drug Administration (FDA) is conducting a series of Patient-Focused Drug Development meetings to hear directly from people living with chronic diseases. One of the upcoming meetings, held this April, will focus on the drug development challenges for sarcopenia.
Sarcopenia is the term that describes age-related loss of muscle and strength that results in functional problems. Adults begin to lose modest amounts of muscle after the age of 30 which then exponentially increases with age. The condition can be present with and complicate outcomes for several other health issues in older adults, including hip fracture, prolonged bed rest, osteoporosis, chronic obstructive pulmonary disease, type 2 diabetes, stroke and congestive heart failure.
The issue is an increasing concern for the US where the number of citizens over the age of 65 is projected to more than double to around 98 million by 2060.1 The estimated economic burden of sarcopenia in the US in 2000 was around $18.5 billion2 – a figure that will increase with a growing older population.
The new meeting – successfully requested by the Alliance for Aging Research through the Aging In Motion (AIM) Coalition – will aim to better inform the process of developing therapies for sarcopenia by collecting real-life patient insights.
The Alliance is currently working with the FDA to identify patients, patient representatives and other interested stakeholders to participate in the meeting, all of which will be given the opportunity to tell the FDA about the daily impact of symptoms and share their perspectives on treatment.
These first-hand stories will guide regulatory activities for currently available and future sarcopenia treatments and help both research institutions and pharmaceutical companies to better inform clinical trial endpoints in accordance with what matters most to those with the condition.
The Alliance is hoping that the FDA will come away from the meeting with a greater understanding of the impact of sarcopenia on patient lives which, in turn, will drive the Administration to work more closely with the research community to improve access to effective therapies – both through developing new treatments and helping the most promising candidates reach patients quicker.
The Patient-Focused Drug Development meeting will take place on April 6, 2017, in Silver Spring, Maryland. It will be a unique opportunity for people living with sarcopenia to tell the FDA how the condition affects their lives. For more information, please visit the Alliance website.
1Administration on Aging (2016). A Profile of Older Americans 2016. Available at: https://aoa.acl.gov/Aging_Statistics/Profile/index.aspx (accessed March 2017).
2Ian Janssen, Donald Shepard, Peter Katzmarzyk, and Ronenn Roubenoff. The healthcare costs of sarcopenia in the United States. Journal of the American Geriatrics Society 2004; 52 (1): 80-85.