Saturday, May 28, 2016

Patient-Focused Drug Development Initiative

The Food and Drug Administration (FDA) announced that Alopecia Areata (AA) was one of eight diseases selected to participate in the Patient-Focused Drug Development Initiative (PFDDI) 2016-2017
 Meetings Planned for FY 2016 – 2017
    • Psoriasis: March 17, 2016
    • Neuropathic pain associated with peripheral neuropathy: June 10, 2016
    • Patients who have received an organ transplant: September 27, 2016
    • Alopecia areata
    • Autism
    • Hereditary angioedema
    • Neuropathic pain associated with peripheral neuropathy
    • Sarcopenia
The FDA will publicly meet with patients who suffer from debilitating conditions without adequate treatment options in the hopes of better understanding their wants and needs in the drug development process.  The meeting will take place in 2016-2017, specific date has not been determined yet.  This can only have a positive impact for disease victims of Alopecia Areata, as the FDA will get a first hand patient perspective of that disease.
CTP-543 is currently in a phase 1 clinical trial for AA, and will commence an efficacy phase 2 trial, first half of 2017.  Concert management has taken the initiative to bring CTP-543 into clinical trials for this disease, which has a very high probability of being the first FDA approved drug for AA.  Next, we will examine the potential market for this indication.  Thank you for reading.


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