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Letter to the FDA in support of approval of Udenafil for Single Ventricle Fontan Patients

On behalf of the over 70,000 people in the United States living with Fontan Circulation, and their families, we request that the U.S. Food and Drug Administration consider and incorporate our experiences, perspectives, and preferences in its review of the New Drug Application (NDA) for Udenafil submitted by Mezzion Pharmaceuticals. Each year, there are 1062 Fontan operations performed each year (15,934 from 2001 to 2014) with a decrease in mortality and post-operative complications. FDA has repeatedly signaled the importance of incorporating patient input into drug development and review, including to us directly by Dr. Norman Stockbridge, Director, Division of Cardiology and Nephrology who invited such information to be provided specifically within the context of the Udenafil NDA. This is especially critical in rare diseases where there are inherent challenges and limitations in designing, conducting, and, as a result, interpreting clinical trials. The 21st Century Cures Act created a framework for FDA to consider the patient perspective by considering our input as “patient experience data.”  


Read the Full Letter Here

Please complete the information below to show your support and have your voice heard by FDA

* First Name and Last Initial of Individual Signing on to the letter of support
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* State of Residence (Or Country if International)
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* Please tell us your connection to the FDA decision
* Would you be willing to share a testimonial to share with the FDA?
How would the availability of a new approved treatment for people with Fontan circulation impact your (or your loved one's) life? Please explain your response, providing personal examples.
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If you had direct experience in the Udenafil Trial, what was your (your child or family member’s) experience with Udenafil? What changes did you notice, if any? Please share your observations by providing personal examples. What would it mean for you (your child or family member) to continue to have access to Udenafil?
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