{"id":104,"date":"2014-04-15T02:08:47","date_gmt":"2014-04-15T02:08:47","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=104"},"modified":"2015-01-14T15:38:35","modified_gmt":"2015-01-14T20:38:35","slug":"fda-adboard-on-tedizolid-why","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2014\/04\/15\/104\/fda-adboard-on-tedizolid-why\/","title":{"rendered":"FDA Adboard on Tedizolid &#8211; Why?"},"content":{"rendered":"<p>FDA\u2019s Advisory Board session for tedizolid (3\/31\/2014) was a foregone affair:\u00a0 Looking at the reviewer\u2019s slides, there was really no question about the drug\u2019s efficacy.\u00a0 Did tedizolid cure as many patients as linezolid?\u00a0 Yes, it did.\u00a0 Did the sponsor follow the latest ABSSSI Guidance criteria for establishing non-inferiority?\u00a0 Yes, they did.\u00a0 Trius even incorporated the latest revision of the Guidance \u2013 based on FNIH (Foundation of the National Institutes of Health) input \u2013 in its Phase 3 confirmatory 113 trial, i.e., lesion-size reduction.\u00a0 In most comparisons and subsets, the efficacy data for both drugs were pretty much superimposable.<!--more--><\/p>\n<p>Safety was also a home-run for tedizolid.\u00a0 GI adverse events were most common but the scrutiny was appropriately focused on neurologic and hematologic changes which did not raise flags of concern.\u00a0 So, the unanimous vote in support of tedizolid by all Ad Board members was justified and &#8211; anticipated.<\/p>\n<p>Was this a trial run and check on the New Guidance, as issued in 2013?\u00a0 Was this meant to show that we now have a path to antibiotic approval that is feasible and science-based, validating the thought process which built on the placebo-controlled Snodberg trials from 1938?\u00a0 I am not sure what the Ad Board contributed and why it was needed.\u00a0 Overall, approx.. 50% of all NDA submissions go to an Ad Board, presumably to assist FDA in its review and to present\u00a0problematic data and equivocal results to an independent outside expert panel for input. \u00a0Not so here: \u00a0this submission was as unproblematic as it gets.<\/p>\n<p>Post Scriptum:<\/p>\n<ul>\n<li>On 6\/22\/2014\u00a0FDA approved\u00a0\u00a0Sivextro (tedizolid) for the treatment of adult acute bacterial skin and skin structure infections (ABSSSI).<\/li>\n<li>Cubist acquired Trius and Tedizolid \/ Sivextro July 30, 2013<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>FDA\u2019s Advisory Board session for tedizolid (3\/31\/2014) was a foregone affair:\u00a0 Looking at the reviewer\u2019s slides, there was really no question about the drug\u2019s efficacy.\u00a0 Did tedizolid cure as many patients as linezolid?\u00a0 Yes, it did.\u00a0 Did the sponsor follow the latest ABSSSI Guidance criteria for establishing non-inferiority?\u00a0 Yes, they <a class=\"more-link\" href=\"https:\/\/allphasepharma.com\/dir\/2014\/04\/15\/104\/fda-adboard-on-tedizolid-why\/\">Continue reading <span class=\"screen-reader-text\">  FDA Adboard on Tedizolid &#8211; Why?<\/span><span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[18],"tags":[81,6,778,92,8,5,343,72,9,185,7,342,90],"class_list":["post-104","post","type-post","status-publish","format-standard","hentry","category-the_viewpoint","tag-absssi","tag-advisory-board","tag-aidac","tag-cubist","tag-efficacy","tag-fda","tag-fnih","tag-linezolid","tag-safety","tag-sivextro-approval","tag-tedizolid","tag-trius","tag-zyvox"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-1G","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":1408,"url":"https:\/\/allphasepharma.com\/dir\/2015\/05\/07\/1408\/no-such-thing-as-a-free-ride\/","url_meta":{"origin":104,"position":0},"title":"No Such Thing as a Free Ride\u2026","author":"Harald","date":"May 7, 2015","format":false,"excerpt":"..when it comes to FDA review of antibiotic NDAs.\u00a0 Some seem to have forgotten the dismal record of antibiotic approvals in the last 15 years, and the long list of failed submissions.\u00a0 Many failed not because of lack of efficacy or a bad safety profile but because of changes in\u2026","rel":"","context":"In &quot;QIDP Antibiotics&quot;","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"theBMJ","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/05\/theBMJ.jpg?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":3116,"url":"https:\/\/allphasepharma.com\/dir\/2017\/01\/30\/3116\/txa-709-kid-qidp-block\/","url_meta":{"origin":104,"position":1},"title":"TXA-709 &#8211;\u00a0 New Kid on the Block","author":"Harald","date":"January 30, 2017","format":false,"excerpt":"When searching for FtsZ inhibitors on PubMed, there are 187 hits. When narrowing down the search looking for clinical trials only, there are none. Taxis Pharmaceuticals obtained QIDP status for its candidate drug TXA-709 in late 2016 and it is still in preclinical testing. The drug\u2019s target, bacterial replication machinery\u2026","rel":"","context":"In &quot;QIDP Antibiotics&quot;","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2017\/01\/FtsZ-slider.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2017\/01\/FtsZ-slider.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2017\/01\/FtsZ-slider.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":1869,"url":"https:\/\/allphasepharma.com\/dir\/2015\/08\/19\/1869\/most-anti-infective-guidelines-get-no-respect-let-alone-use\/","url_meta":{"origin":104,"position":2},"title":"Most Anti-Infective Guidelines Don&#8217;t Get No Respect (Let Alone Use!)","author":"Harald","date":"August 19, 2015","format":false,"excerpt":"It is no secret that most existing antibiotic guidelines are not getting much use these days.\u00a0 The only indications pursued with any regularity are the feasible ones: ABSSSI, cUTI, and cIAI, much less CABP.\u00a0 Yes, the occasional HABP\/VABP trial is being undertaken by the intrepid but no company has taken\u2026","rel":"","context":"In &quot;Did you know...?&quot;","block_context":{"text":"Did you know...?","link":"https:\/\/allphasepharma.com\/dir\/category\/interesting_facts\/"},"img":{"alt_text":"indications - slider","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/08\/indications-slider.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/08\/indications-slider.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/08\/indications-slider.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":3577,"url":"https:\/\/allphasepharma.com\/dir\/2025\/06\/02\/3577\/__trashed-2__trashed\/","url_meta":{"origin":104,"position":3},"title":"The 10 x \u201920 Initiative &#8211; A Retrospective","author":"Harald","date":"June 2, 2025","format":false,"excerpt":"It started all so well with fanfare and great expectations.\u00a0Fifteen years ago, the 10 x \u201920 initiative got underway. Its goals were spelled out clearly: To \u2018Pursue a Global Commitment to Develop 10 New Antibacterial Drugs by 2020 \u2019[3].\u00a0 It was driven by ID clinicians and by antibiotic developers concerned\u2026","rel":"","context":"In &quot;Did you know...?&quot;","block_context":{"text":"Did you know...?","link":"https:\/\/allphasepharma.com\/dir\/category\/interesting_facts\/"},"img":{"alt_text":"BBND","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2020\/06\/BBND.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2020\/06\/BBND.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2020\/06\/BBND.jpg?resize=525%2C300&ssl=1 1.5x"},"classes":[]},{"id":157,"url":"https:\/\/allphasepharma.com\/dir\/2014\/04\/22\/157\/antibiotics-with-qidp-designation\/","url_meta":{"origin":104,"position":4},"title":"Antibiotics with QIDP Designation &#8211;   &#8211;    &#8211;  Updated 9-30-14","author":"Harald","date":"April 22, 2014","format":false,"excerpt":"For the latest QIDP listing, please click HERE \u00a0 Since\u00a0FDA issued the QIDP designation in 2012, many companies have requested this important 'label'. \u00a0Which should not come as a surprise: QIDP status confers significant benefits - and there is no downside. While an official FDA list of drugs that have\u2026","rel":"","context":"In &quot;QIDP Antibiotics&quot;","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/04\/FDA-GAIN-LPAD-banner-copy.jpg?fit=640%2C200&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/04\/FDA-GAIN-LPAD-banner-copy.jpg?fit=640%2C200&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/04\/FDA-GAIN-LPAD-banner-copy.jpg?fit=640%2C200&ssl=1&resize=525%2C300 1.5x"},"classes":[]},{"id":2205,"url":"https:\/\/allphasepharma.com\/dir\/2015\/12\/23\/2205\/qidp-antibiotics-2015-year-end-update\/","url_meta":{"origin":104,"position":5},"title":"QIDP Antibiotics  &#8211;  2015 Year-End Update","author":"Harald","date":"December 23, 2015","format":false,"excerpt":"Here an updated listing of all QIDP drugs we are aware of as of 12\/24\/2015. Today just\u00a0facts and numbers; we will provide an interpretation of the current landscape in upcoming blogs. There are\u00a058 drugs which garnered QIDP status and these are listed in the Main Table below. With the recent\u2026","rel":"","context":"In &quot;QIDP Antibiotics&quot;","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/12\/QIDP-slider.jpg?fit=640%2C200&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/12\/QIDP-slider.jpg?fit=640%2C200&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/12\/QIDP-slider.jpg?fit=640%2C200&ssl=1&resize=525%2C300 1.5x"},"classes":[]}],"jetpack_likes_enabled":true,"_links":{"self":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/104","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/comments?post=104"}],"version-history":[{"count":13,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/104\/revisions"}],"predecessor-version":[{"id":1231,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/104\/revisions\/1231"}],"wp:attachment":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/media?parent=104"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/categories?post=104"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/tags?post=104"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}