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":415189,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[3846],"tags":[128388,142547,142546,142549,2460,30287,267,64790,142545,142548,6448,2444,142542,70,142544,142550,142543,1017,16,15],"class_list":["post-415188","post","type-post","status-publish","format-standard","has-post-thumbnail","category-genetics","tag-bioworld","tag-complete-response-letter","tag-crl","tag-endocrine-metabolic","tag-fda","tag-genetic-disorder","tag-genetics","tag-nda","tag-pyruvate-dehydrogenase-complex-deficiency","tag-pyruvate-dehydrogenase-kinase-inhibitor","tag-rare-disease","tag-regulatory","tag-saol-therapeutics-inc","tag-science","tag-sl-1009","tag-small-molecule","tag-sodium-dichloroacetate","tag-u-s","tag-uk","tag-united-kingdom"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@uk\/115184413271668829","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/415188","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/comments?post=415188"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/415188\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media\/415189"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media?parent=415188"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/categories?post=415188"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/tags?post=415188"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}