{"id":7655,"date":"2026-08-27T04:41:39","date_gmt":"2026-08-27T10:41:39","guid":{"rendered":"https:\/\/allphasepharma.com\/dir\/?p=7655"},"modified":"2026-08-27T05:05:44","modified_gmt":"2026-08-27T11:05:44","slug":"avacopan-tavneos-follow-up","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2026\/08\/27\/7655\/avacopan-tavneos-follow-up\/","title":{"rendered":"Avacopan \/ TAVNEOS Follow-Up"},"content":{"rendered":"
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\"\"<\/a><\/figure>\n<\/div>\n\n

There was not much for us to report on this summer that would interest our readership…<\/p>\n

Let\u2019s skip the Fauci \/ Paul senate drama regarding the origins of Covid, with senator Paul taking the role of the Grand Inquisitor and Dr. Fauci the Fifth. The latest act in this screen play introduced no new facts, only a bit of human hubris.\u00a0<\/span>The senate dialogue \u2013 or monologue in this case \u2013 sounded like a 1950s House Un-American Activities Committee (HUAC) hearing.\u00a0 No new facts for sure.<\/p>\n

The second and more entertaining summer show is still going on; Amgen\u2019s handling of avacopan \/ TAVNEOS. Unless you live behind the hills, you certainly heard about Chemocentryx and how they reportedly misrepresented the outcome data from the pivotal ADVOCATE trial in ANCA vasculitis. Much of this was uncovered only after approval. When the FDA learned late last year that the company had \u2018re-adjudicated\u2019 the original data, it threatened withdrawal of the drug.<\/p>\n

Detective work by consultant Dr. Walden identified the scheming machinations of some C-suite actors who had hidden the original non-inferior non-superior outcome results, thereby snatching victory from the jaws of defeat. The Walden report is not in the public domain to the best of our knowledge. We have to take the FDA\u2019s word for it, as regards the sequence of events around the time of unblinding and the role played by statisticians, the Adjudication Committee (AC), and company execs.<\/p>\n

Several regulatory agencies worldwide reacted to the new information by rescinding the TAVNEOS approval (EMA, TSA, others), but not so the FDA which appears strangely ambivalent, almost benevolent. While FDA provided a multi-page explanation why TAVNEOS no longer meets approvability criteria and should be recalled, they offered Amgen an Advisory meeting for final \u2018adjudication\u2019. The company since obtained an independent reanalysis of the pivotal study data from DCRI which \u2013 surprise! – confirmed that TAVNEOS did not achieve the required superiority at the 1-yr timepoint. Nevertheless, the FDA has taken no action yet.<\/p>\n

The NEJM retraction of the 2021 article of the ADVOCATE study was a correct and needed step.[1]\u00a0 Why did they exculpate the 2 academic (sic!) authors of the retracted article by saying that data re-adjudication occurred \u201cwithout the knowledge of these two authors\u201d. This strikes us as hypocritical. The first author, DRW Joyce, was the head of the independent Adjudication Committee (AC); in that capacity he and others must have been informed of the goings-on, esp. the post-unblinding re-adjudication. While we don\u2019t have all the details, it looks like several people played roughshod with the study\u2019s Stat Plan and the AC charter.<\/p>\n

Another interesting statement can be found in a Lancet Editorial entitled \u2018The end is near for Avacopan\u2019.[2]\u00a0 \u00a0The review mentions the controversy surrounding the ADVOCATE study, but emphasizes post-approval trials. The editors conclude that the \u201ctotality of the evidence suggests benefit for patients across a range of outcomes\u201d.\u00a0<\/p>\n

How come? What a twisted logic! Is this the new back-door way to get new compounds into patient care?\u00a0 Never mind the outcome of the pivotal trial program, just conduct a series of compelling \u2018real-world\u2019 studies and get approval with the support of benevolent experts and patient testimonials.<\/p>\n

Avacopan may be a useful drug in some C5 inhibitor indications, but this hypothesis is still unproven. The drug may even have a role to play in ANCA vasculitis, but the ADVOCATE study did not measure up and only showed a trend. Justifying the use of avacopan with post-marketing \u2018real-world\u2019 efficacy data is a smoke screen.<\/p>\n

The company could have run a second trial in ANCA or trials in PNH. They chose not to. They took a risk, knowing that the drug\u2019s fate would depend on showing superiority at the 52-wk primary endpoint. No ifs, ands or buts. When they saw the unblinded data, they panicked.<\/p>\n

We wonder if senator Rand Paul has heard of the avacopan story. If he finds out that Fauci sponsored \u2018gain-of-function\u2019 research for avacopan at the Wuhan lab, we will be treated to yet another hot investigation. Just kidding, of course!<\/p>\n

Who would have thought that the lazy hot late summer days of 2026 would hold so much entertainment value!<\/p>\n

ABBREVIATIONS<\/strong>
ANCA\u00a0 \u00a0 \u00a0 antinuclear cytoplasmic antibody
AC\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0adjudication committee
DCRI\u00a0 \u00a0 \u00a0 \u00a0Duke Clinical Research Institute
PNH\u00a0 \u00a0 \u00a0 \u00a0 \u00a0paroxysmal nocturnal hemoglobinuria
TGA\u00a0 \u00a0 \u00a0 \u00a0 \u00a0Therapeutic Goods Administration (Australia)<\/p>\n

REFERENCES
<\/strong>[1] Rubin W.\u00a0 Retraction: Jayne DRW et al. Avacopan for the Treatment of ANCA-Associated Vasculitis, N Engl J Med 2021;384:599\u00a0 DOI: 10.1056\/NEJMe2608684
[2]\u00a0 Editorial.\u00a0 The end for avacopan.\u00a0 The Lancet Rheumatology. Published Online July 10, 2026 https:\/\/doi.org\/10.1016\/S2665-9913(26)00225-0<\/p>\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

There was not much for us to report on this summer that would interest our readership… Let\u2019s skip the Fauci \/ Paul senate drama regarding the origins of Covid, with senator Paul taking the role of the Grand Inquisitor and Dr. Fauci the Fifth. The latest act in this screen Continue reading Avacopan \/ TAVNEOS Follow-Up<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":7658,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[227,3,18],"tags":[2736,2740,1271,2727,637,2715,2728,2743,2737,2741,625,5,2733,1583,2742,2738,2734,2744,2735,2730,2739,2731,2716,2313,2732],"class_list":["post-7655","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-recent_literature","category-the_news","category-the_viewpoint","tag-adjudication-committee","tag-advocate-study","tag-allphase-pharma-consulting","tag-amgen","tag-anthony-fauci","tag-avacopan","tag-chemocentryx","tag-complement-c5-receptor-inhibitor","tag-data-unblinding-process","tag-dcri","tag-ema","tag-fda","tag-gain-of-function","tag-harald-reinhart","tag-lancet-rheumatology","tag-new-england-journal-retraction","tag-pivotal-trial","tag-pnh","tag-post-marketing-trial","tag-rand-paul","tag-revocation-of-market-authorization","tag-senate-hearing","tag-tavneos","tag-tga","tag-wuhan-lab"],"yoast_head":"\nAvacopan \/ TAVNEOS Follow-Up - Allphase Pharma Consulting, LLC<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/allphasepharma.com\/dir\/2026\/08\/27\/7655\/avacopan-tavneos-follow-up\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Avacopan \/ TAVNEOS Follow-Up - Allphase Pharma Consulting, LLC\" \/>\n<meta property=\"og:description\" content=\"There was not much for us to report on this summer that would interest our readership… Let\u2019s skip the Fauci \/ Paul senate drama regarding the origins of Covid, with senator Paul taking the role of the Grand Inquisitor and Dr. Fauci the Fifth. 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