FDA’s Patient-Focused Drug Development Initiative Selects Eight Diseases

The FDA has selected eight new disease areas to focus on over the next two years under its Patient-Focused Drug Development Initiative.

The eight conditions are alopecia areata, autism, hereditary angioedema, nontuberculous mycobacterial infections, organ transplants, psoriasis, neuropathic pain associated with peripheral neuropathy and sarcopenia.

Six of the conditions were included in a list of 16 proposed last fall.

The FDA selected the disease areas based on considerations including whether the conditions are chronic and symptomatic, affect daily activities, have limited or no therapies, or have a severe impact on identifiable subpopulations.

The PFDD initiative is being conducted to fulfill the agency’s commitments under PDUFA V.

The 10 diseases removed from last October’s proposed list are achondroplasia, autoimmune disorders treated with immune globulins, depression, diabetic foot infections, melanoma specifically unresectable loco-regional disease, neurological disorders treated with immune globulins, ovarian cancer, primary humoral immune deficiencies, pruritis and thrombotic disorders.

Read the notice here: www.fdanews.com/07-15/7-15-FDA-PFDD.pdf. — Jonathon Shacat