The APF, on behalf of our members, views this change in review date as an unacceptable delay by the FDA.
The American Porphyria Foundation, on behalf of our members, views this change in review date as an unacceptable delay by the Food and Drug Administration. Patients with Erythropoietic Protoporphyria (EPP) have waited long enough for a full review of this treatment that has shown to be safe and effective over a dozen years of use and has been approved by the European Medicines Agency. It is not acceptable and unsustainable that U.S. patients only have access to Scenesse through great expense and travel. It is time for the FDA to #approveScenesse.
We encourage you to contact your LEGISLATORS and MEDIA! Share the story of EPP and Scenesse.
CONTACT YOUR REPRESENTATIVES:
Contact Congressional and Local Representatives
This link will share your state and local representatives. You can call OR write – or both! It is ok to talk to a health aide who represents a legislator. Please copy the APF on your communication – firstname.lastname@example.org.
07/2008 - Scenesse granted Orphan Drug Designation
07/2016 - Scenesse granted Fast Track Designation
10/24/2016 - Scientific Workshop held at the FDA, White Oak, MD – 125 patients
1/8/2019 - New Drug Application Submitted and Priority Review granted
(6-month review time period indicating there is an UNMET MEDICAL NEED in this disease).
07/08/2019 - PDUFA (Prescription Drug User Fee Act) REVIEW DATE under Priority Review
10/06/2019 - DELAYED REVIEW DATE! 3 MONTH DELAY.
Letters and calls can include:
MEDIA: The APF is preparing a press release to share with media.