Patient Focused Drug Development Meeting on Krabbe Disease

NORD invites you to register for an externally-led Patient-Focused Drug Development (EL- PFDD) virtual meeting on Krabbe disease, taking place Thursday, October 29, 12:30 – 4:30 pm ET. Patients and caregivers impacted by Krabbe disease who are interested in potentially speaking at the meeting as panelists should be sure to fill out this form by August 7.

If you are a patient, family member or caregiver affected by Krabbe disease, this is an important opportunity to have your voice heard by the US Food and Drug Administration (FDA).

EL-PFDD meetings provide an opportunity for patients, their families and caregivers to share critical information about the impact of their disease on their daily lives and their experiences with currently available treatments. Patients’ experiences provide valuable insight for the FDA and other key stakeholders, including researchers, medical product developers and health care providers.

Krabbe disease (pronounced krab-A) is a rare genetic disorder, also known as globoid cell leukodystrophy. It is described as a severe neurological condition caused by a deficiency of the enzyme galactocerebrosidase (GALC). About 1 in 100,000 newborn babies in the United States are affected with Krabbe disease, with males and females equally affected. Krabbe disease is seen most commonly in infants, but it can also develop later in life. Unfortunately, there is currently no cure for Krabbe disease, and it is commonly fatal. Like many lysosomal storage disorders, there is a wide range of disease symptoms impacting the age of onset and disease severity. Since it damages a person’s central and peripheral nervous systems, complications include: feeding difficulties, blindness, deafness, seizures, severe loss of muscle tone, and respiratory failure.

NORD strives to collect rigorous patient experience data from Krabbe disease patients and caregivers that can guide medical product development and assist regulatory agencies in conducting assessment and review of potential therapies for patients with Krabbe disease, given the lack of available treatment options for these patients.

The goals of this EL-PFDD meeting are to provide researchers, drug developers and FDA with a robust understanding of patients’ and caregivers’ experiences with Krabbe disease, including how individuals with Krabbe disease view their quality of life, what aspects of the disease are most problematic for them, and what actions they currently perform to treat and cope with this disease. The results of this meeting will be shared publicly in a “Voice of the Patient” report inan effort to inform the development of potential treatments that can improve the lives of patients living with Krabbe disease.

Visit https://bit.ly/NORD-krabbe-pfdd for ongoing information and updates on the meeting.