A phase 3 trial of statin intolerant patients called ODYSSEY ran for 65 weeks. Results were presented at the 2014 European Society of Cardiology meeting. A 78-week study of alirocumab in 2341 people taking statins who were at high risk for cardiovascular events and had high LDL cholesterol levels was published in April 2015. This study showed a significant reduction of LDL cholesterol levels in patients taking both Alirocumab and oral statins compared to placebo patients solely taking oral statins. Studies are ongoing to assess the effects of alirocumab in normocholesterolemic individuals.In July 2014, Regeneron and Sanofi announced that they had purchased a priority review voucher that BioMarin had won for a recent rare disease drug approval for $67.5 million; the voucher cut four months off the regulatory review time for alirocumab and was part of their strategy to beat Amgen to market with the first approval of a PCSK9 inhibitor.In July 2015, the FDA approved alirocumab as a second-line treatment to lower LDL cholesterol for adults who have hereditary high cholesterol and people with atherosclerosis who require additional lowering of LDL cholesterol when diet and statin treatment have not worked. This was the first approval of a PCSK9 inhibitor. The FDA approval was contingent on the completion of further clinical trials to better determine efficacy and safety.Regeneron and Amgen had each filed for patent protection on their monoclonal antibodies and the companies ended up in patent litigation in the U.S.
Earlier reports suggested that 90% of cases stay in remission after discontinuation of treatment, but this is at odds with more recent studies, which suggest that relapse commonly occurs after initial high-dose steroid treatment. Left untreated, this condition can result in coma and death. Epidemiology
The prevalence has been estimated to be 2.1/100,000 with a male-to-female ratio of 1:4. The mean age of onset is 44 with 20% of cases presenting before the age of 18 years. Most reported cases occur during the patients fifth decade of life. History
The first case of HE was described by Brain et al. in 1966. The patient was a 48-year-old man with hypothyroidism, multiple episodes of encephalopathy, stroke-like symptoms, and Hashimotos thyroiditis confirmed by elevated antithyroid antibodies. Alternative names
Steroid-responsive encephalopathy associated with autoimmune thyroiditis, SREAT
Nonvasculitic autoimmune meningoencephalitis, NAIM
Encephalopathy associated with autoimmune thyroid disease, EAATD

References
Further reading
Hashimotos Encephalopathy SREAT Alliance (2013). Understanding Hashimotos Encephalopathy: A Guide for Patients, Families, and Caregivers, Featuring Stories of HE Patients from Around the World. North Charleston, SC: CreateSpace Independent Publishing Platform. ISBN 9781484883099. OCLC 890816771. Schiess N, Pardo CA (October 2008). "Hashimotos encephalopathy". Annals of the New York Academy of Sciences. 1142 (1): 254–65. Bibcode:2008NYASA1142..254S. doi:10.1196/annals.1444.018. PMID 18990131. S2CID 1312798. Taylor SE, Garalda ME, Tudor-Williams G, Martinez-Alier N (February 2003). "An organic cause of neuropsychiatric illness in adolescence". The Lancet. 361 (9357): 572. doi:10.1016/S0140-6736(03)12517-2. PMID 12598143. S2CID 35053683.