The most common non-infectious sources of genital ulcers are first Behcets disease, and second drug reaction.Behcets syndrome is a chronic systemic vasculitis infection that is defined by recurrent oral and genital aphthous ulcers but can also affect many other organ systems, such as the eyes, ears, nervous system, heart, lungs, joints, and intestines. Behcets syndrome commonly presents in the 30-40 age range and is more common in the Middle East and Asia. There is a familial component to Behcets syndrome since it has associations with the HLA-B51 gene.Causes of drug induced genital ulcers take the form of Stevens–Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and fixed drug eruptions in response to a diverse list of medications. Stevens–Johnson syndrome and toxic epidermal necrolysis are more likely than erythema multiforme to have genital manifestations although all present with a toxic appearing patient. A fixed drug eruption in comparison does not present as a toxic appearing patient but rather single or multiple erythematous patches that vary in size and shape which eventually turn dark brown in color and become itchy. The defining characteristic is that these drug eruptions appear in the same location each time the offending medication is used, and will resolve on their own.Other potential causes of non-infectious genital ulcers are diverse, but can include sexual trauma, Lipschutz ulcers, inflammatory bowel diseases such as Crohns disease, lichen planus, lichen sclerosis, and immunobullous disease such as pemphigous vulgaris, since bullous pemphigoid is less likely to occur on the genitals.
The sponsorship for the drug was transferred several times over the following years: from Amicus Therapeutics to Shire Pharmaceuticals in 2008, back to Amicus in 2010, to Glaxo in 2011, and again to Amicus in 2014.Two phase III clinical trials with a total of about 110 subjects were conducted between 2009 and 2015, one double-blind comparing the drug to placebo, and one comparing it to recombinant α-GalA without blinding. Migalastat stabilised heart and kidney function over the 30-months period of these trials.In September 2015, Amicus announced that it would submit a new drug application (NDA) for accelerated approval of migalastat to the FDA by the end of 2015. The CHMP recommended approval in April 2016, but the FDA rejected the application in November for having insufficient data in November 2016. The drug was approved in the European Union in May 2016. Germany was the first country where migalastat was launched. After Scott Gottlieb became FDA commissioner in 2017, the CEO of Amicus began lobbying him directly for the FDA to accept the NDA and in February 2018 the FDA accepted it and promised a response by August 2018. See also
Miglustat, a drug for the treatment of Gaucher disease, with a similar structure
1-Deoxynojirimycin, a stereoisomer of migalastat

References
External links
"Migalastat". Drug Information Portal. U.S. National Library of Medicine.