Thursday, February 4, 2016

Write your Congressman EPP PATIENTS!!!

Write your Congressman

Your 300 letters to the FDA regarding EPP were VERY effective. We are gaining ground! EPP is now on their radar. BUT we need your help. Now we need everyone to contact their congressmen and urge them to contact the FDA directly.
Here is the link to find each of your congressmen with one easy search:
You may submit your letters via mail OR email. The website shown above provides you with all contact information. Below we have provided a template letter you may use, or, better yet, please write one of your own. The more letters, the better! Thank you all!

"Remember...research is the key to your cure!!"
[Insert Date]

The Honorable _________________
[Insert your Congressman's address here]

Dear Mr. ________,
As a person who has been diagnosed with Erythropoietic Protoporphyria (EPP), I am very concerned that the FDA has not approved Afamelanotide, a revolutionary drug to treat EPP. EPP is a rare, extremely photosensitive disease that causes severe burning of the skin, liver damage, Vitamin D deficiency and other major health problems. In other words, sunlight causes children and adults to suffer, and no one can avoid sunlight. When we discovered this drug would allow us to drive to work without pain, spend a day in the sun with our families and even do simple acts like walk to our cars without burning severely, we began to demand that the FDA approve Afamelanotide.
The EMA approved Afamelanotide in Europe in October 2014. In fact, almost half of worldwide patients can receive Afamelanotide for EPP, while US citizens have no FDA approval and continue to suffer. Instead, EPP patients in the US are forced to travel at great expense to purchase the drug in Switzerland. The demand has escalated to the point that people are asking for Congressional and media help. Recently, NBC, ABC, CNN, FOX, Telemundo and a host of other networks reported on EPP and this new treatment.
The American Porphyria Foundation, their Scientific Advisory Board and Porphyria Research Consortium, who performed the research, all recommend that the FDA approve Afamelanotide. As of yet, the FDA has not assessed the data from the clinical trials. Clinuvel, the drug manufacturer, cannot file a New Drug Application until the FDA assesses the data and allows their filing.
Afamelanotide has a long, safe and effective history. This timeline purports the readiness for this drug to receive accelerated approval.
• Trials for EPP started in 2006. Since then, there have been five clinical trials. In all other indications, including healthy volunteers, there have been more than 15 trials. More than 1,000 patients have received the drug. This is extremely important in that EPP is considered an ultra-rare disease, therefore, the numbers herein mean that a large part of the EPP population has been tested with the drug.
• Since 2006, a total of 146 patients continuously have been on Afamelanotide on a compassionate basis as part of the Special Access Schemes in Switzerland and Italy. The FDA has never allowed patients to have Afamelanotide on a compassionate basis.
• The European Medicines Agency (EMA) approved Afamelanotide for EPP on October 24, 2014. The FDA is keenly aware that Afamelanotide was approved in Europe as FDA representatives attended the plenary session in September 2014 before the EMA approval. The European Medicines Agency took record time to assess the novel and challenging nature of EPP and the unusual mode of action of the drug.
Most important to all of the EPP community is the FDA has not allowed trials for children. Every FDA delay adds five years to these children ever having access to the drug. While we await FDA approval of Afamelanotide, the FDA has approved treatments for wrinkle cream and double chin. Meanwhile, the EPP community suffers with severe pain and liver damage when a tiny implant of Afamelanotide would provide us with a normal life.
Please ask the FDA to grant accelerated approval for Afamelanotide.


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[Insert your name here]
Age, [insert] years old
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