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The Voice of the Patient The Voice of the Patient The Voice of the Patient Summary report resulting from an Externally Led Patient-Focused Drug Development meeting, a parallel effort to the U.S. Food and Drug Administration’s (FDA’s) Patient-Focused Drug Development Initiative Friedreich’s Ataxia Externally Led Public Meeting: June 2, 2017 Report Date: August 20, 2017 Hosted by: Friedreich’s Ataxia Research Alliance, Muscular Dystrophy Association, National Ataxia Foundation, and Cure FA Foundation Submitted to: Center for Drug Evaluation and Research (CDER) & Center for Biologic Evaluation and Research (CBER) U.S. Food and Drug Administration (FDA) This report represents the summary report composed by patient advocacy organizations as a result of an Externally Led Patient-Focused Drug Development meeting, a parallel effort to the FDA’s Patient Focused Drug Development Initiative. This report reflects the host organization’s account of the perspectives of patients and caregivers that participated in the public meeting. 1 Table of Contents Table of Contents ............................................................................................................................ 2 Introduction: .................................................................................................................................... 3 Overview of Friedreich’s Ataxia: ................................................................................................... 3 Meeting Overview: ......................................................................................................................... 4 Report Overview and Key Themes: ................................................................................................ 5 Topic 1: Living with Friedreich’s Ataxia ...................................................................................... 7 Disease Symptoms: ..................................................................................................................... 8 Disease Symptoms: Balance and Walking ............................................................................ 8 Disease Symptoms: Fatigue ................................................................................................... 9 Disease Symptoms: Manual Dexterity................................................................................. 10 Disease Symptoms: Speech and Hearing ............................................................................. 10 Disease Symptoms: Vision .................................................................................................. 11 Disease Symptoms: Cardiomyopathy .................................................................................. 11 Disease Symptoms: Other .................................................................................................... 11 Everyday Life with FA ............................................................................................................. 12 Topic 2: Patient Perspectives on Current and Future Approaches for Treating FA. ................... 14 Symptom Management: Medications ....................................................................................... 14 Symptom Management: Scoliosis............................................................................................. 15 Symptom Management: Cardiac............................................................................................... 15 Symptom Management: Other Surgeries .................................................................................. 16 Symptom Management: Other Interventions ............................................................................ 16 Perspectives on Clinical Trials.................................................................................................. 17 Perspectives on Future Treatments ........................................................................................... 18 Conclusions: .................................................................................................................................. 20 References: .................................................................................................................................... 20 Appendix 1: Incorporating Patient Input into a Benefit-Risk Framework for Friedreich’s Ataxia ....................................................................................................................................................... 21 Appendix 2: Meeting Agenda. ...................................................................................................... 23 Appendix 3: Meeting Panelists .................................................................................................... 25 Appendix 4: Discussion Questions .............................................................................................. 26 Appendix 5: Polling Questions ..................................................................................................... 30 Appendix 6: Full Results from Polling Questions ....................................................................... 36 Appendix 7: Patient / Caregiver Testimonies ............................................................................. 55 2 Introduction: On June 2nd 2017, The Friedreich’s Ataxia Research Alliance (FARA), Muscular Dystrophy Association (MDA), National Ataxia Foundation (NAF), and Cure FA Foundation co-sponsored an Externally Led Patient-Focused Drug Development meeting for Friedreich’s Ataxia (FA). The goal of the meeting was to give FA patients, their families and caregivers a forum to discuss their perspectives on living with the disease: what symptoms they experience, how it affects their lives, what concerns them about the disease, their opinions on current and future treatment options, and experiences with research studies and clinical trials. The meeting was formatted in a manner similar to the FDA-led Patient-Focused Drug Development Meetings, which were set up to more systematically gather patients’ perspectives on their condition and available therapies to treat their disease (https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm347317.htm). Overview of Friedreich’s Ataxia: Friedreich’s ataxia (FA) is a debilitating, life-shortening, progressive degenerative neuromuscular disorder that affects approximately 1 in every 50,000 people in Caucasian populations of Europe, the Middle East, South Asia (Indian subcontinent) and North Africa. Incidence is very rare in other ethnic groups1. Although rare, it is the most common form of inherited ataxia. FA is an autosomal recessive, single gene disorder, caused by mutations in the frataxin gene. In most cases, it is caused by an expanded GAA triplet repeat in intron 1 of the frataxin gene but, in about 4% of cases, patients have a triplet repeat expansion on one allele and a point mutation in the frataxin gene on the other allele2. Diagnosis is typically by genetic testing, which detects about 99% of all cases. About 75% of patients are diagnosed between 6 and 20 years of age, while about 22% are diagnosed after 21 years of age. Loss of balance and coordination is the most common presenting symptom, typically beginning between the ages of 5 and 15 years with progression of symptoms leading to loss of ambulation and independence of all activities of daily living. Adult or late-onset FA is less common and occurs after the age of 25. Patients with point mutations may have slightly different disease course than those with two expanded repeats. FA is multi-systemic, affecting the neurological system – e.g., balance, fine motor skills, sight, and hearing – and also the heart, skeletal muscle, skeleton (scoliosis, pes cavus), and digestive system (diabetes). While neurological features of the disease are fully penetrant, affecting 100% of those diagnosed, other systems are not affected in all patients. Two thirds of patients develop cardiomyopathy, more than half develop severe scoliosis and the incidence of diabetes is between 10 and 40%.3 The mean age at death is 35 years, due to cardiac complications in greater than 50% of individuals.4 3 The first symptom identified is frequently ataxia - loss of coordination and balance - but, in some cases, cardiomyopathy or scoliosis may precede onset of neurological disease. Symptoms such as vision impairment, hearing loss, swallowing difficulties and urinary disturbances are generally more prominent in late-stage disease. On careful examination, however, signs of these symptoms are often detectable in patients early in progression. By end-stage disease, about 95% of patients will have myocardial involvement. Shinnick et al reported that FA patients also have a higher incidence than unaffected people of certain other diseases, such as ulcerative colitis, Crohn’s disease, inflammatory bowel disease and growth hormone deficiency5. However, incidence of these conditions is still low in the FA population. The progressive loss of coordination and muscle strength leads to motor incapacitation and the full-time use of a wheelchair, typically within 10-15 years of diagnosis. Most young people diagnosed with FA require mobility aids such as a cane, walker, or wheelchair by their teens or early 20s. Intelligence of people with FA remains completely intact, although subtle differences in cognition can be detected. There are no approved therapies for FA. Meeting Overview: The meeting provided the FDA and drug developers with an opportunity to hear from patients,
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