Call To Action

  • Thursday, June 20, 2019

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 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 –

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

Letters and calls can include:

  • Information on EPP:
    Erythropoetic Protoporphyria (EPP) is an ultra-rare genetic disease characterized by severe phototoxicity. Exposure to visible light (sunlight and artificial lighting) causes a chemical reaction akin to a radiation burn. A reaction results in intolerable pain.
  • Your Story
    Impact of EPP on your quality of life and the burden of living with this disease. Include if you participated in a clinical trial and how the treatment affected you.
  • Information on Scenesse
    SCENESSE® (pronounced “sen-esse”) acts by increasing the levels of melanin in the skin; and shields against UV radiation (UVR) and sunlight. SCENESSE® is delivered via a subcutaneous dissolving implant approximately the size of a grain of rice. Increased pigmentation of the skin appears after two days and lasts up to two months.
  • Your “ASK”
    Please request that the FDA completes a full review immediately and approves Scenesse!

MEDIA: The APF is preparing a press release to share with media.