The Lung Transplant Foundation (LTF), a non-profit organization dedicated to creating a world where all lung transplant patients live long, healthy lives, announced today it will host an externally-led patient-focused drug development meeting with the U.S. Food and Drug Administration (FDA) on Wednesday, June 22, 2022 from 10:00 a.m. – 3:00 p.m. ET in Washington DC.
| ~ Meeting to be Held Wed., June 22, 2022 from 10:00 a.m. – 3:00 p.m. ET in Washington DC.; Event will be Livestreamed for Virtual Attendees ~ ~ Bronchiolitis Obliterans Syndrome (BOS) is One of the Most Severe Complications After Lung Transplantation; Currently, There are No Approved Treatment Options ~ ~ An Estimated 50% of Lung Transplant Patients Develop BOS within Five Years Post-Transplant ~ CARY, N.C., June 15, 2022 /PRNewswire/ -- The Lung Transplant Foundation (LTF), a non-profit organization dedicated to creating a world where all lung transplant patients live long, healthy lives, announced today it will host an externally-led patient-focused drug development meeting with the U.S. Food and Drug Administration (FDA) on Wednesday, June 22, 2022 from 10:00 a.m. – 3:00 p.m. ET in Washington DC. This historic event is intended to help educate the Agency and the public about the challenges of living with Bronchiolitis Obliterans Syndrome (BOS).
“Bronchiolitis Obliterans Syndrome (BOS) is one of the most severe complications after lung transplantation” BOS, also referred to as chronic rejection, is one of the most severe complications after lung transplantation. Approximately 50 percent of lung transplant patients develop BOS within five years post-transplant[i], the highest rejection rate of any transplanted organ. BOS usually leads to respiratory failure and death within 2 to 4 years after diagnosis[ii], underscoring the immense need for effective treatment options. “This is the first time that regulators and policymakers on the Hill will hear directly from patients and caregivers about what it is like to live with BOS, a disease that represents an incredibly high physical, emotional and economic burden on patients, their caregivers and the healthcare system,” said Amy Skiba, executive director of The Lung Transplant Foundation. “We believe that understanding the patient journey can help the FDA make more informed decisions as they review potential therapies for BOS and will assist pharmaceutical companies in the design of clinical trials for BOS patients.” The June 22 Meeting will be a Livestream and will include patient testimonials, as well as remote audience participation (register here). The meeting agenda will focus on two patient panels and audience discussion sessions on living with BOS, treatments for the disease, and potential clinical trials for BOS. LTF encourages patients and caregivers impacted by or at risk of developing BOS to take a brief survey here. The anonymous information gathered will be used to help guide and inform content for this meeting as well as future LTF activities. “While lung transplants give recipients a second chance of life, unfortunately, an estimated 50 percent of recipients will develop BOS five years post-transplant and be faced with no approved treatment options,” said John Michael Reynolds, M.D., associate professor of pulmonary, allergy and critical care medicine at Duke University School Medicine. “As clinicians, we applaud the LTF for leading the way for transplant patients who have already faced an incredibly long and arduous journey with lung disease and eagerly welcome new therapeutic options to help change a patient’s prognosis, should BOS occur.” The burden of BOS on the healthcare system is significant. Double lung transplantation costs in the U.S. are estimated to be over $1 million.[iii] Meanwhile, the per patient mean direct costs in the U.S. for treating lung transplant recipients with BOS exceed $150,000 in the year following diagnosis compared to transplant recipients without BOS.[iv] LTF would like to thank our participating sponsors, Altavant Sciences, patientMpower, Zambon USA Ltd. and Mallinckrodt Pharmaceuticals for helping to make this event possible. About The Lung Transplant Foundation: The Lung Transplant Foundation (LTF) was founded as a non-profit organization by a group of lung transplant recipients from Durham and Chapel Hill, NC. Since 2009, we have raised funds and have been an advocate for lung transplant research. We also provide education and emotional support for transplant recipients and their caregivers through our Mentorship. We can’t do it alone. We invite you to help us breathe life into lung transplant research by making a donation or learning more about how you can be involved. [i] Weigt, et al. Semin Respir Crit Care Med. 2013;34(3):336–351. Organization Contact: Amy Skiba, Executive Director, LTF Media Relations Contacts: Elixir Health Public Relations Jennifer Price
SOURCE The Lung Transplant Foundation |
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