The U.S. FDA issued a complete response letter (CRL) for the NDA to privately held Saol Therapeutics Inc.\u2019s rare disease treatment, sodium dichloroacetate (SL-1009), for pyruvate dehydrogenase complex deficiency. The inhibitor of pyruvate dehydrogenase kinases is the only drug in development for treating the rare genetic disorder, according to Cortellis. There are no FDA-approved treatments for the disease.<\/p>\n
BioWorld<\/a> Regulatory<\/a> Endocrine\/metabolic<\/a> Small molecule<\/a> U.S.<\/a> FDA<\/a> NDA<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"The U.S. FDA issued a complete response letter (CRL) for the NDA to privately held Saol Therapeutics Inc.\u2019s…\n","protected":false},"author":2,"featured_media":127279,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[25],"tags":[43720,60252,60251,60255,7552,10708,916,60253,60250,60254,20202,29672,60247,90,60249,60256,60248,5134,56,54,55],"class_list":{"0":"post-127278","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-genetics","8":"tag-bioworld","9":"tag-complete-response-letter","10":"tag-crl","11":"tag-endocrine-metabolic","12":"tag-fda","13":"tag-genetic-disorder","14":"tag-genetics","15":"tag-nda","16":"tag-pyruvate-dehydrogenase-complex-deficiency","17":"tag-pyruvate-dehydrogenase-kinase-inhibitor","18":"tag-rare-disease","19":"tag-regulatory","20":"tag-saol-therapeutics-inc","21":"tag-science","22":"tag-sl-1009","23":"tag-small-molecule","24":"tag-sodium-dichloroacetate","25":"tag-u-s","26":"tag-uk","27":"tag-united-kingdom","28":"tag-unitedkingdom"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/127278","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/comments?post=127278"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/127278\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media\/127279"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media?parent=127278"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/categories?post=127278"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/tags?post=127278"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}