{"id":37293,"date":"2026-06-18T02:59:31","date_gmt":"2026-06-18T02:59:31","guid":{"rendered":"https:\/\/www.europesays.com\/france\/37293\/"},"modified":"2026-06-18T02:59:31","modified_gmt":"2026-06-18T02:59:31","slug":"after-a-2-month-delay-sanofi-gains-fda-expansion-of-tzield","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/france\/37293\/","title":{"rendered":"After a 2-month delay, Sanofi gains FDA expansion of Tzield"},"content":{"rendered":"

After accepting Sanofi\u2019s application for an expansion of its Type 1 diabetes treatment Tzield and putting it in the fast lane for a potential approval under a controversial new pathway, the FDA has signed off<\/a> on the expansion, albeit nearly two months later than the original target date.\u00a0<\/p>\n

The accelerated nod will allow patients ages 8 to 17 who have been recently diagnosed with stage 3 Type 1 diabetes to use Tzield to delay the decline in endogenous insulin production. The monoclonal antibody was first approved<\/a> four years ago by the FDA to delay the onset of stage 3 diabetes in those with stage 2 disease.\u00a0<\/p>\n

Sanofi\u2019s expansion bid was accepted under former FDA chief Marty Makary\u2019s Commissioner\u2019s National Priority Voucher (CNPV) program<\/a>, with the agency originally eyeing an April 21 decision.<\/p>\n

\u00a0After the date came and went without a complete response letter (CRL), Stat reported<\/a> that the acting director of the FDA\u2019s Center for Drug Evaluation and Research (CDER) at the time, Tracy Beth Hoeg, M.D., Ph.D., overturned a staff decision to endorse the expansion and that Sanofi had asked that the application be pulled from the CNPV program.<\/p>\n

In the span of a few days last month, Makary resigned<\/a> and Hoeg was fired<\/a>, with Makary\u2019s departure raising questions about the status of the CNPV program. Since it was established, the initiative was criticized<\/a> as a potential tool for government officials to curry favor and reward political allies in the biopharma industry.<\/p>\n

Of the first wave of nine drugmakers who got CNPVs, Sanofi was among those who did not apply. The FDA\u00a0nominated<\/a>\u00a0the company to receive one because its application addressed an unmet need, Sanofi said upon accepting the nomination in October of last year.\u00a0<\/p>\n

On Monday, a Sanofi spokesperson said that Tzield was no longer part of the CNPV program.<\/p>\n

\u201cThe FDA has informed us that it will no longer be conducting an advisory committee meeting,\u201d the spokesperson added in an email. \u201cDuring the continued review process, all outstanding questions were clarified, enabling the FDA to grant the accelerated approval.\u201d<\/p>\n

The nod was backed by data from the Protect phase 3 study of 328 participants ages 8 to 17 who had been diagnosed with stage 3 diabetes within the last six weeks. Tzield slowed the decline in C-peptide levels compared to placebo. C-peptide<\/a> is a short chain of amino acids released into the bloodstream in equal amounts to insulin production.<\/p>\n

\u201cWe now have a novel therapy that targets the autoimmune and progressive nature of stage 3 type 1 diabetes,\u201d\u00a0Aaron J. Kowalski, Ph.D., the CEO of Breakthrough T1D, said in a statement.\u00a0\u201cApproximately 64,000 people are diagnosed with T1D every year. We are excited that the approval of Tzield in this indication provides a treatment option for certain patients diagnosed in stage 3 T1D.\u201d<\/p>\n

Sanofi added that Tzield is not effective as a disease-modifying therapy in non-autoimmune dysglycemic conditions.<\/p>\n

Sanofi currently is enrolling patients in a confirmatory phase 3 study, which is designed to demonstrate the clinical benefit of Tzield in the indication. The Protect trial was based on a surrogate C-peptide endpoint deemed likely to show clinical benefit.\u00a0<\/p>\n

The nod comes on top of an FDA expansion<\/a> two months ago for Tzield to treat patients age 1 and older. Last year, Sanofi reported sales of Tzield at 68 million euros ($77 million).<\/p>\n","protected":false},"excerpt":{"rendered":"After accepting Sanofi\u2019s application for an expansion of its Type 1 diabetes treatment Tzield and putting it in…\n","protected":false},"author":2,"featured_media":37294,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[12983],"tags":[26152,13377,26153,22749,13012,25080],"class_list":["post-37293","post","type-post","status-publish","format-standard","has-post-thumbnail","category-sanofi","tag-commissioners-national-priority-voucher-cnpv","tag-fda","tag-fierce-pharma-homepage","tag-pharma","tag-sanofi","tag-type-1-diabetes"],"_links":{"self":[{"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/posts\/37293","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/comments?post=37293"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/posts\/37293\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/media\/37294"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/media?parent=37293"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/categories?post=37293"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/france\/wp-json\/wp\/v2\/tags?post=37293"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}