The FDA will hold a first-ever public workshop on April 25-26, 2013, to discuss how best to facilitate and expedite the development of safe, effective drug therapies to treat myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The workshop is open to pharmaceutical companies, researchers, clinicians and patients, and it will be live-streamed online.
Currently there are no FDA-approved medications for ME/CFS, leaving patients, which number more than 1 million, with no hope for a cure or treatment. Recently, the FDA raised the significance of ME/CFS by declaring it a "serious disease or set of diseases for which there are no approved treatments." This designation, combined with what is now known about the biology of the disease and the opportunities to repurpose existing drugs, gives patients hope that drug companies will take advantage of an expedited drug development and approval process to invest in drugs for ME/CFS.
This meeting will be of interest to pharmaceutical companies that deal with neurological, immunological, viral and autoimmune diseases or with repurposing of existing drugs. Information about the FDA meeting was published in the Federal Register and the Pink Sheet.
ME/CFS is a disabling disease that causes severe dysfunction of neurological, immune, endocrine and energy production systems. Recent studies indicate it may be due to a virus or be an autoimmune disease. ME/CFS is characterized by nonrestorative sleep, cognitive impairments, orthostatic intolerance, debilitating weakness, pain, fever and the hallmark symptom of post-exertional malaise which causes severe relapse upon minimal mental or physical exertion.
