I’m thrilled to announce that NARCOLEPSY has been selected for FDA’s Patient-focused Drug Development Initiative (PFDDI). Narcolepsy has been selected as one of the initial 12 disease areas for individual evaluation to be addressed in FY 2013 – FY 2015.
We did it!
I testified in person and led the campaign for online comments. And did you help me?
“Over half of the comments received concerned lung cancer, narcolepsy, and interstitial lung disease,” FDA’s official announcement states here.
Thank you for supporting my efforts. Together, we raised our voices and FDA heard us!
FDA will conduct a public meeting to discuss the disease and its impact on patients’ daily lives, the types of treatment benefit that matter most to patients, and patients’ perspectives on the adequacy of available therapies. These meetings will include participation of FDA review divisions, the relevant patient community, and other interested stakeholders.
Narcolepsy is scheduled to be addressed later this year starting in Sept 2013. This initiative will allow FDA to better understand the patient perspective in evaluating any upcoming narcolepsy treatments for FDA approval. As hypocretin agonists become more of a reality for future narcolepsy treatment, this is an exciting opportunity for patients to aid FDA in understanding what matters most to us. For full details, visit the FDA website.
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For updated posts about the FDA Initiative, click here.