{"id":2136,"date":"2007-10-02T18:46:04","date_gmt":"2007-10-02T17:46:04","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=2136"},"modified":"2013-09-12T16:17:06","modified_gmt":"2013-09-12T16:17:06","slug":"roche-withdraw-application-for-biojector-needle-free-option-for-t-20","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/2136","title":{"rendered":"Roche withdraw application for Biojector needle-free option for T-20"},"content":{"rendered":"<p><strong>On 3 October, Roche and Trimeris announced that they are withdrawing a supplement application for approval to market Biojector B2000 as a &#8216;needle-free&#8217; option for delivery of T-20 (enfuvirtide).<\/strong> [1]<\/p>\n<p>The reasons for not continuing with the applications was given as &#8216;based on comprehensive assessment of the clinical program, as well a significant delay in achieving U.S. regulatory approval due to the time required to generate additional data&#8217;.<\/p>\n<p>It has been over three years since the first studies showing similar pharmacokinetics and the potential for better tolerability using Biojector compared to regular injections. [2, 3] Safety concerns in larger studies included an increased risk of nerve damage and haematoma.<\/p>\n<p>Patients in the UK are not able to access Biojector as the manufacturer does not have a European license for this device.<\/p>\n<p>Patients currently using Biojector in the US through an expanded safety trial may be able to continue to use the device, as it is still commercially available there.<\/p>\n<p class=\"ref\">References:<\/p>\n<ol>\n<li>Press release: Roche and Trimeris provide update on development of alternative administration options for delivery of FUZEON: Companies withdraw application to market Biojector\u00ae 2000 device for use with Fuzeon. (03.10.07)<br \/>\n<a href=\"http:\/\/www.roche.com\/\">http:\/\/www.roche.com<\/a><\/li>\n<li>Needle-free injections for T-20 in the US. HIV Treatment Bulletin, April 2005.<br \/>\n<a href=\"#\">http:\/\/www.i-base.info\/htb\/v6\/htb6-4\/Needle.html<\/a><\/li>\n<li>T-20 studies presented at Rio. HIV Treatment Bulletin, September 2005.<br \/>\n<a href=\"#\">http:\/\/www.i-base.info\/htb\/v6\/htb6-9\/T20.html<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>On 3 October, Roche and Trimeris announced that they are withdrawing a supplement application for approval to market Biojector B2000 as a &#8216;needle-free&#8217; option for delivery of T-20 (enfuvirtide). [1] The reasons for not continuing with the applications was given &hellip;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-2136","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/2136","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=2136"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/2136\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=2136"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=2136"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=2136"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}