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FDA to Hold Public Teleconference on October 16 on Myalgic Encephalomyelitis / Chronic Fatigue Syndrome Drug Development



10/16/2013 9:28:48 AM

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WASHINGTON -- October 16, 2013 - PANDORA Org and many ME/CFS patients will participate in the FDA Chronic Fatigue Syndrome and Myalgic Encephalomyelitis (CFS and ME) Stakeholder teleconference on October 16 from 1:30 p.m.–3 p.m. EDT. PANDORA Org's goal is to motivate the FDA to bring pharmaceutical and biotech companies to the table in a second workshop.

"There are no FDA-approved therapies for this devastating disease, and patients need access to treatments now," said Lori Chapo-Kroger, RN, president and CEO of PANDORA Org. "Now that the FDA has a better understanding of the disease impact, as shown by their Patient Voice Report of their April meeting with patients, they need to open the drug development door wider so patients can find some relief from their suffering. To make this happen, the FDA needs to include the pharmaceutical companies and ME/CFS clinical experts in a workshop focused on developing outcome measures, what they failed to do in April."

In a September 2012 Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation, President Barack Obama's Council of Advisors on Science and Technology states that the FDA should expand the scope of acceptable endpoints used to approve drugs for serious or life-threatening diseases with unmet needs.

"Certainly, this goal should be applied to drug development for ME/CFS, which the FDA classifies as a serious or life-threatening disease with unmet needs," said Chapo-Kroger.

The drug that has progressed furthest in the drug approval process is Ampligen (developed by Hemispherx Biopharma), which has been in trials for decades. Rituximab (developed by Biogen Idec and Genentech) is also showing promise in trials of ME/CFS patients. "The researchers and clinical experts involved in these studies are some of the top ME/CFS experts in the world and have the experience to know what outcome measures are best for ME/CFS drug trials," said Chapo-Kroger. "Leaving them out of an outcome measures discussion is a mistake and a tragedy for our patient community who are fighting to survive every day."

After the background remarks, the FDA will open the teleconference discussion for public comments on the following three topics:

* Feedback from the ME/CFS public workshop that was held April 25-26.

* Current projects related to drug development in ME/CFS.

* Potential methods to catalyze ME/CFS drug development.

The FDA's Patient-Focused Drug Development initiative is a commitment under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V) that aims to more systematically gather patients' perspectives on their condition and available therapies to treat their condition.

The announcement of the October 16 teleconference can be found at http://www.fda.gov/Drugs/NewsEvents/ucm370166.htm.

Registration for the FDA call will be open until October 11, 2013. For more details, please visit: https://cfsmeteleconference2013.eventbrite.com/.

The September 2012 report to the president can be found at www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-fda-final.pdf

About PANDORA Org

PANDORA Org is a national nonprofit organization seeking to alleviate the suffering caused by neuro-endocrine-immune diseases (NEIDs), including ME/CFS, Fibromyalgia, chronic Lyme disease and Gulf War illnesses. For more information visit: www.pandoraorg.net.

For More Information Contact:

Lori Chapo-Kroger

LoriKroger@pandoraorg.net

231-360-6830

SOURCE: PANDORA Org

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